A Study to Learn Safety and Blood Levels of PF-07817883 i... | NCT05580003 | Trialant
NCT05580003
Sponsor
Pfizer
Status
Completed
Last Update Posted
Nov 21, 2024Actual
Enrollment
94Actual
Phase
Phase 1
Conditions
Healthy
Interventions
PF-07817883
Placebo
Midazolam
Moxifloxacin
Countries
United States
Belgium
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05580003
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C5091001
Secondary IDs
ID
Type
Description
Link
2022-002871-12
EudraCT Number
2022-002871-12
Registry Identifier
CTIS (EU)
Brief Title
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
Official Title
COVID-19: A MULTIPART, PHASE 1 STUDY WITH RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07817883 AND OPTIONAL OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE RELATIVE BIOAVAILABILITY AND FOOD EFFECT OF SOLID ORAL FORMULATION AND OPTIONAL OPEN-LABEL, NON-RANDOMIZED STUDY TO EVALUATE METABOLISM AND EXCRETION OF PF-07817883 AND OPTIONAL RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE EFFECT OF PF-07817883 ON PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY ADULT PARTICIPANTS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Sep 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 17, 2022Actual
Primary Completion Date
Sep 15, 2023Actual
Completion Date
Sep 15, 2023Actual
First Submitted Date
Oct 11, 2022
First Submission Date that Met QC Criteria
Oct 11, 2022
First Posted Date
Oct 14, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Sep 12, 2024
Results First Submitted that Met QC Criteria
Sep 12, 2024
Results First Posted Date
Nov 21, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 12, 2024
Last Update Posted Date
Nov 21, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19. Participants will take PF-07817883 by mouth up to 2 times a day. This study may also evaluate how much PF-07817883 gets into the body when taken as pill. We may study if people's diets can affect this study medicine. We may also examine how PF-07817883 is processed and removed by the human body. Finally, we may look into if PF-07817883 has potential to interact with midazolam.
Detailed Description
Combined 6-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3: Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Drug-drug interaction with midazolam Part-6: Supratherapeutic exposure Part-1,2 and 6 are double blind, sponsor open and Part-3,4 and 5 are open label study.
Conditions Module
Conditions
Healthy
Keywords
Oral Antiviral
COVID-19
Protease Inhibitor
Mpro
PF-07817883
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
94Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-07817883 Dose 1 in PART-1
Experimental
Drug: PF-07817883
PF-07817883 Dose 2 in PART-1
Experimental
Drug: PF-07817883
PF-07817883 Dose 3 in PART-1
Experimental
Drug: PF-07817883
PF-07817883 Dose 4 in PART-1
Experimental
Drug: PF-07817883
PF-07817883 Dose 5 in PART-1
Experimental
Optional dose levels
Drug: PF-07817883
PF-07817883 Dose 6 in PART-1
Experimental
Optional dose levels
Drug: PF-07817883
Placebo in PART-1
Placebo Comparator
A single dose of placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-07817883
Drug
Oral suspension or solid oral formulation(s)
Midazolam 5 mg with PF-07817883 in PART-5
PF-07817883 DR1 in PART-2
PF-07817883 DR2 in PART-2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)
Part 1: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: (lymphocytes less than (<) 0.8*lower limit of normal [LLN] [10^3 per millimeter cube {mm3}], lymphocytes/leukocytes <0.8*LLN [percentage {%}], neutrophils <0.8*LLN [10^3/mm3], neutrophils/leukocytes <0.8*LLN [%], monocytes/leukocytes greater than (>) 1.2*upper limit of normal [ULN] [%], partial thromboplastin time >1.1*ULN [seconds]), chemistry (bicarbonate <0.9*LLN [milliequivalents per liter {mEq/L}], creatine kinase >2.0*ULN [units per liter {U/L}], lipase >1.5*ULN [U/L]), and urinalysis (urine hemoglobin greater than or equal to [>=] 1, leukocyte esterase >=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (<) 90 millimeter of mercury (mmHg), change greater than or equal to (>=) 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 beats per minute (bpm), value > 120 bpm.
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Maximum Observed Concentration (Cmax) of PF-07817883
Cmax of PF-07817883 was reported in this outcome measure.
Healthy male or female subjects between ages of 18-60 years. Male only in part-4.
Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs). A body weight of >45 kg may be considered in selected cases.
Japanese subjects who have four Japanese biologic grandparents born in Japan
Chinese participants who were born in mainland China and both parents are of the Chinese descent.
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection).
Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.
Have received COVID-19 vaccine within 7 days before screening or have received only one of the 2 required doses of COVID-19 vaccine
Use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day
Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
60 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
New Haven Clinical Research Unit
New Haven
Connecticut
06511
United States
Pfizer Clinical Research Unit - Brussels
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
A total of 94 participants were enrolled across Belgium and United States.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
P1: C1: Placebo,Fast/PF-07817883 1500mg,Fast/PF-07817883 4000mg, Fast
In this cohort (C), participants received a single dose of placebo as an oral suspension in the fasted (fast) state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 milligram (mg) as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
FG007
Part 2: Placebo (Suspension) BID, Fasted
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
FG008
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
FG009
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
FG010
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
FG011
Part 2: Placebo (Suspension) BID, Fasted, Chinese
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
FG012
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
FG013
Part 3: Treatment Sequence ABCD
Participants received treatments A, B, C and D in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 spray dried dispersion (SDD) 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
FG014
Part 3: Treatment Sequence BCAD
Participants received treatments B, C, A and D in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
FG015
Part 3: Treatment Sequence CABD
Participants received treatments C, A, B and D in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
FG016
Part 3: Treatment Sequence BACE
Participants received treatments B, A, C and E in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
FG017
Part 3: Treatment Sequence ACBE
Participants received treatments A, C, B and E in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
FG018
Part 3: Treatment Sequence CBAE
Participants received treatments C, B, A and E in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
FG019
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
FG020
Part 5: Treatment Sequence AB
Participants received a single dose of midazolam 5 mg orally on Day 1 of Period 1 followed by a 2-day washout period. In Period 2, participants received PF-07817883 BID orally for 10 days followed by single dose of midazolam 5 mg on Day 10 followed by a washout of at least 7 days.
FG021
Part 5: Treatment Sequence BA
In Period 1, participants received PF-07817883 BID orally for 10 days and on Day 10, participants received a single oral dose of 5 mg midazolam administered with PF-07817883 followed by a washout of at least 7 days. In Period 2, participants received a single dose of midazolam 5 mg orally followed by a 2-day washout period.
FG022
Part 6: Treatment Sequence ABC
Participants received treatment A, B and C in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
FG023
Part 6: Treatment Sequence BCA
Participants received treatment B, C and A in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
FG024
Part 6: Treatment Sequence CAB
Participants received treatment C, A and B in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
FG025
Part 6: Treatment Sequence BAC
Participants received treatment B, A and C in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
FG026
Part 6: Treatment Sequence ACB
Participants received treatment A, C and B in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
FG027
Part 6: Treatment Sequence CBA
Participants received treatment C, B and A in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
Periods
Title
Milestones
Reasons Not Completed
Part (P) 1 Treatment Period 1 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 1: Washout 1 (up to 5 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjectsParticipants who started washout 1 of Part 1.
FG0012 subjectsParticipants who started washout 1 of Part 1.
FG0022 subjectsParticipants who started washout 1 of Part 1.
FG003
Part 1 Treatment Period 2 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0002 subjectsParticipants who started Period 2 of Part 1.
FG0012 subjectsParticipants who started Period 2 of Part 1.
FG0022 subjectsParticipants who started Period 2 of Part 1.
FG003
Part 1: Washout 2 (up to 5 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjectsParticipants who started washout 2 of Part 1.
FG0012 subjectsParticipants who started washout 2 of Part 1.
FG0022 subjectsParticipants who started washout 2 of Part 1.
FG003
Part 1: Treatment Period 3 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0002 subjectsParticipants who started Period 3 of Part 1.
FG0012 subjectsParticipants who started Period 3 of Part 1.
FG0022 subjectsParticipants who started Period 3 of Part 1.
FG003
Part 2 (up to 10 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3 Period 1 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3: Washout 1 (up to 3 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3: Period 2 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3: Washout 2 (up to 3 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3: Period 3 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3: Washout 3 (up to 3 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3: Period 4 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 4 (Day 1 to Day 11)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 5: Sequence AB: Period 1 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 5:SequenceAB:Washout1(Upto 2 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part5:SequenceAB:Period2(up to 10 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part5:Sequence AB:Washout2(up to 7 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part5:Sequence BA:Period1(up to 10 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part5:Sequence BA:Washout1(up to 7 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 5: Sequence BA: Period 2 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part5:Sequence BA:Washout2(up to 2 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 6 Period 1 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 6: Washout 1 (up to 7 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 6 Period 2 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 6: Washout 2 (up to 7 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 6 Period 3 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
P1: C1: Placebo,Fast/PF-07817883 1500mg,Fast/PF-07817883 4000mg, Fast
In this cohort (C), participants received a single dose of placebo as an oral suspension in the fasted (fast) state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 milligram (mg) as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Data for arm - ''Part 2: Placebo (Suspension) BID, Fasted, Chinese'' is not disclosed to avoid risk of identification and kept under ''Not disclosed'' category.
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)
ID
Title
Description
OG000
Placebo (Suspension), Fasted
Adverse Events Module
Frequency Threshold
5
Time Frame
Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Description
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Placebo (Suspension), Fasted
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
PART-1 and -2 are a randomized, double-blind, sponsor-open, placebo-controlled trial to evaluate safety, tolerability and PK of single and multiple escalating oral doses of PF 07817883 in healthy adult participants, respectively. PART-1 is crossover while PART-2 is parallel cohort study design. PART-2 of the study may also evaluate the safety, tolerability and PK in Japanese and Chinese participants. PART-3 is a randomized, open-label, cross-over, study to evaluate relative bioavailability and food effect of up to 2 new PF 07817883 oral formulations. PART-4 is an open label, non-randomized, single period cohort to evaluate the metabolism and excretion of PF 07817883. PART-5 is an open-label, randomized, cross-over cohort to evaluate the effect of steady state PF-07817883 on PK of midazolam in healthy participants. PART-6 is a sponsor-open, randomized, 3-treatment, 3-period, cross over study to evaluate safety, tolerability, and PK of PF 07817883 at supratherapeutic exposure.
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
PART-1, 2 and 6 are double-blind, sponsor-open while PART-3, 4 and 5 are open label
Who Masked
ParticipantInvestigator
Drug: Placebo
PF-07817883 DR1 in PART-2
Experimental
DR=Dosing regimen; twice a day
Drug: PF-07817883
PF-07817883 DR2 in PART-2
Experimental
Drug: PF-07817883
PF-07817883 DR3 in PART-2
Experimental
Optional dosing regimen
Drug: PF-07817883
PF-07817883 DR4 in PART-2
Experimental
Optional dosing regimen
Drug: PF-07817883
PF-07817883 in Japanese in PART-2
Experimental
Optional dosing regimen to be studied in Japanese population
Drug: PF-07817883
PF-07817883 in Chinese in PART-2
Experimental
Optional dosing regimen to be studied in Chinese population
Drug: PF-07817883
Placebo in PART-2
Placebo Comparator
Drug: Placebo
PF-07817883 Suspension Fasted in PART-3
Experimental
PART-3 is optional
Drug: PF-07817883
PF-07817883 FORM-1 Fasted in PART-3
Experimental
First solid oral formulation (FORM1)
Drug: PF-07817883
PF-07817883 FORM-2 Fasted in PART-3
Experimental
Second solid oral formulations (FORM-2) is optional
Drug: PF-07817883
PF-07817883 FORM-1 Fed in PART-3
Experimental
Drug: PF-07817883
PF-07817883 FORM-2 Fed in PART-3
Experimental
Drug: PF-07817883
PF-07817883 in PART-4
Experimental
PART-4 is optional
Drug: PF-07817883
Midazolam 5 mg in PART-5
Experimental
Single dose of 5 mg alone
Drug: Midazolam
Midazolam 5 mg with PF-07817883 in PART-5
Experimental
Single dose of 5 mg on Day 10 with multiple doses (twice a day) of PF-07817883
Drug: PF-07817883
Drug: Midazolam
PF-07817883 in PART-6
Experimental
A single dose at supratherapeutic exposure administered as divided doses (1h apart)
Drug: PF-07817883
Placebo in PART-6
Placebo Comparator
A single dose of placebo administered as divided doses (1h apart)
Drug: Placebo
Moxifloxacin 400 mg in PART-6 (open label)
Active Comparator
Moxifloxacin 400 mg at 0h followed by placebo at 1h
Drug: Placebo
Drug: Moxifloxacin
PF-07817883 DR3 in PART-2
PF-07817883 DR4 in PART-2
PF-07817883 Dose 1 in PART-1
PF-07817883 Dose 2 in PART-1
PF-07817883 Dose 3 in PART-1
PF-07817883 Dose 4 in PART-1
PF-07817883 Dose 5 in PART-1
PF-07817883 Dose 6 in PART-1
PF-07817883 FORM-1 Fasted in PART-3
PF-07817883 FORM-1 Fed in PART-3
PF-07817883 FORM-2 Fasted in PART-3
PF-07817883 FORM-2 Fed in PART-3
PF-07817883 Suspension Fasted in PART-3
PF-07817883 in Chinese in PART-2
PF-07817883 in Japanese in PART-2
PF-07817883 in PART-4
PF-07817883 in PART-6
Placebo
Drug
Placebo suspension
Moxifloxacin 400 mg in PART-6 (open label)
Placebo in PART-1
Placebo in PART-2
Placebo in PART-6
Midazolam
Drug
midazolam oral solution
Midazolam 5 mg in PART-5
Midazolam 5 mg with PF-07817883 in PART-5
Moxifloxacin
Drug
Moxifloxacin 400 mg tablet
Moxifloxacin 400 mg in PART-6 (open label)
Up to Day 2 of each period
Part 1: Number of Participants With Electrocardiogram (ECG) Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Up to Day 2 of each period
Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)
Part 2: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (lymphocytes/leukocytes >1.2*ULN [%], neutrophils <0.8*LLN [10^3/mm3], neutrophils/leukocytes <0.8*LLN [%], monocytes/leukocytes >1.2*ULN [%]), chemistry (urate >1.2*ULN [milligrams per deciliter] {mg/dL}), and urinalysis (ketones >=1, urine hemoglobin >=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)
Part 2: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.
Up to Day 12
Part 2: Number of Participants With Electrocardiogram (ECG) Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Up to Day 12
Part 3:Ratio Based on Area Under Plasma Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) and Area Under Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of Oral Formulation and Suspension
Data for AUClast and AUCinf are reported in the descriptive section. AUClast was calculated by the linear/log trapezoidal method. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. Ratio based on AUClast and AUCinf of oral formulation and suspension were reported in statistical analysis.
Part 4: Percentage of Total Dose Administered Recovered in Urine
The percentage of total dose administered recovered in urine was reported in this outcome measure.
Up to 144 hours post-dose
Part 4: Percentage of Total Dose Administered Recovered in Feces
The percentage of total dose administered recovered in feces was reported in this outcome measure.
Up to 144 hours post-dose
Part 4: Percentage of Total Dose Administered Recovered in Urine and Feces
The percentage of total dose administered recovered in urine and feces was reported in this outcome measure.
Up to 144 hours post-dose
Part 5: Maximum Observed Concentration (Cmax) of Midazolam
Cmax of midazolam was reported in this outcome measure.
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Part 5: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Midazolam
AUCinf of midazolam was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Part 6: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)
Part 6: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (lymphocytes <0.6*LLN [10^3/mm3], lymphocytes/leukocytes >1.2*ULN [%], neutrophils <0.8*LLN [10^3/mm3], neutrophils/leukocytes <0.8*LLN [%], basophils/leukocytes >1.2*ULN [%], eosinophils/leukocytes >1.2*ULN [%], monocytes/leukocytes >1.2*ULN [%], partial thromboplastin time >1.1*ULN [seconds], prothrombin time >1.1*ULN [seconds]), chemistry (bicarbonate <0.9*LLN [mEq/L], creatine kinase > 2.0*ULN [U/L], lipase > 1.5*ULN [U/L], urobilinogen >=1 [ehrlich units/deciliter] {EU/dL}) and urinalysis (urine hemoglobin >=1, leukocyte esterase >=1, ketones >=1, bacteria >20 [per low power field] {/lpf}). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm.
Up to Day 6 of each period
Part 6: Number of Participants According to Categorization of ECG Data
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured QTcF interval, aggregate 450 milliseconds (msec) < value <= 480 msec and QTcF interval, aggregate 30 msec < change <= 60 msec. Number of participants with abnormalities in ECG were reported in this outcome measure.
Up to Day 6 of each period
Tmax of PF-07817883 was reported in this outcome measure.
Part 1: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Part 2: Maximum Observed Concentration (Cmax) of PF-07817883 on Days 1, 5 and 10
Cmax of PF-07817883 was reported in this outcome measure.
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
Part 2: Time for Cmax (Tmax) of PF-07817883 on Days 1, 5 and 10
Tmax of PF-07817883 was reported in this outcome measure.
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
Part 2: Area Under the Plasma Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) of PF-07817883 on Days 1, 5 and 10
AUCtau was defined as area under the plasma concentration-time profile from time 0 to time tau, the dosing interval, where tau= 12 hours. AUCtau of PF-07817883 was reported in this outcome measure. AUCtau was calculated by linear/log trapezoidal method.
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
Part 2: Concentration at 12 Hour Nominal Time Post-Dose (C12) of PF-07817883 on Days 5 and 10
C12 of PF-07817883 was reported in this outcome measure.
12 hours on Day 5 and Day 10
Part 2: Dose Normalized Cmax (Cmax[dn]) of PF-07817883 on Days 1, 5 and 10
Cmax(dn) of PF-07817883 was reported in this outcome measure. Cmax(dn) was calculated as Cmax/dose.
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
Part 2: Dose Normalized AUCtau (AUCtau[dn]) of PF-07817883 on Days 1, 5 and 10
AUCtau(dn) was defined as dose normalized AUCtau, where tau= 12 hours. AUCtau(dn) of PF-07817883 was reported in this outcome measure. AUCtau(dn) was calculated as AUCtau/dose.
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
Part 2: Average Concentration (Cav) of PF-07817883 on Days 5 and 10
Cav of PF-07817883 was reported in this outcome measure. Cav was calculated as AUCtau/12.
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
Part 2: Observed Accumulation Ratio for AUCtau (Rac) of PF-07817883 on Days 5 and 10
Rac was defined as observed accumulation ratio for AUCtau, where tau= 12 hours. Rac of PF-07817883 was reported in this outcome measure. Rac was calculated as AUCtau on Day 5 or Day 10/AUCtau on Day 1.
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
Part 2: Observed Accumulation Ratio for Cmax (Rac,Cmax) of PF-07817883 on Days 5 and 10
Rac,Cmax of PF-07817883 was reported in this outcome measure. Rac,Cmax was calculated as Cmax on Day 5 or Day 10/Cmax on Day 1.
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
Part 2: Peak-to-Trough Ratio (PTR) of PF-07817883 on Days 5 and 10
PTR of PF-07817883 was reported in this outcome measure. PTR was calculated as Cmax/Cmin.
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
Part 2: Apparent Clearance (CL/F) of PF-07817883 on Days 5 and 10
CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
Part 2: Apparent Volume of Distribution (Vz/F) of PF-07817883 on Day 10
Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau*kel).
Part 2: Terminal Half-Life (t1/2) of PF-07817883 on Day 10
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Part 2: Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of PF-07817883 on Day 10
Aetau was defined as amount excreted in urine as unchanged drug over the dosing interval tau, where tau= 12 hours. Aetau of PF-07817883 was reported in this outcome measure. Aetau was calculated as sum of (urine volume*urine concentration) for each collection over the dosing interval.
Day 10 (0 to 12 hours)
Part 2: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of PF-07817883 on Day 10
Aetau% was defined as percentage of dose excreted in urine as unchanged drug over the dosing interval tau, where tau= 12 hours. Aetau% of PF-07817883 was reported in this outcome measure. Aetau% was calculated as 100*Aetau/dose.
Day 10 (0 to 12 hours)
Part 2: Renal Clearance (CLr) of PF-07817883 on Day 10
CLr of PF-07817883 was reported in this outcome measure. CLr was calculated as Aetau/AUCtau.
Day 10 (0 to 12 hours)
Part 3: Ratio Based on AUClast and AUCinf of Tablet Formulation Under Fed Condition and Fasted Condition
Data for AUClast and AUCinf are reported in the descriptive section. AUClast was calculated by the linear/log trapezoidal method. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. Ratio based on AUClast and AUCinf of tablet formulations under fed and fasted conditions were reported in statistical analysis.
Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Tablet Formulation Under Fed Condition and Fasted Condition
Data for Cmax are reported in the descriptive section. Ratio based on Cmax of tablet formulation under fed and fasted conditions were reported in statistical analysis.
Part 3: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 days)
Part 3: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (monocytes/leukocytes >1.2*ULN [%], partial thromboplastin time >1.1*ULN [seconds]) and urinalysis (urine hemoglobin >=1, bacteria >20 [/lpf]). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 days)
Part 3: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.
Up to Day 3 of each period
Part 3: Number of Participants With ECG Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Up to Day 3 of each period
Part 4: Time for Cmax (Tmax) of PF-07817883
Tmax of PF-07817883 was reported in this outcome measure.
Part 4: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 days)
Part 4: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (mean corpuscular volume <0.9*LLN [cubic micrometer {um^3}], mean corpuscular hemoglobin <0.9*LLN [picograms per cell {pg/cell}], monocytes/leukocytes >1.2*ULN [%]). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 days)
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm.
Up to Day 11
Part 4: Number of Participants With ECG Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Up to Day 11
Part 5: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
Part 5: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (lymphocytes <0.8*LLN [10^3/mm3], lymphocytes/leukocytes <0.8*LLN [%], neutrophils/leukocytes <0.8*LLN [%], monocytes/leukocytes >1.2*ULN [%]), chemistry (amylase >1.5*ULN [units/liter] {U/L}), and urinalysis (urine hemoglobin >=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm.
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
Part 5: Number of Participants With ECG Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
Part 5: Time for Cmax (Tmax) of Midazolam
Tmax of midazolam was reported in this outcome measure.
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Part 5: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam
AUClast of midazolam was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Part 5: Terminal Half-Life (t1/2) of Midazolam
t1/2 of midazolam was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Part 5: Apparent Clearance (CL/F) of Midazolam
CL/F of midazolam was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Part 5: Apparent Volume of Distribution (Vz/F) of Midazolam
Vz/F of midazolam was reported in this outcome measure. Vz/F was calculated as dose/(AUCinf*kel).
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Part 6: Maximum Observed Concentration (Cmax) of PF-07817883
Cmax of PF-07817883 was reported in this outcome measure.
Part 6: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
BG007
Part 2: Placebo (Suspension) BID, Fasted
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
BG008
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
BG009
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
BG010
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
BG011
Part 2: Placebo (Suspension) BID, Fasted, Chinese
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
BG012
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
BG013
Part 3: Treatment Sequence ABCD
Participants received treatments A, B, C and D in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 spray dried dispersion (SDD) 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
BG014
Part 3: Treatment Sequence BCAD
Participants received treatments B, C, A and D in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
BG015
Part 3: Treatment Sequence CABD
Participants received treatments C, A, B and D in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
BG016
Part 3: Treatment Sequence BACE
Participants received treatments B, A, C and E in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
BG017
Part 3: Treatment Sequence ACBE
Participants received treatments A, C, B and E in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
BG018
Part 3: Treatment Sequence CBAE
Participants received treatments C, B, A and E in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
BG019
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
BG020
Part 5: Treatment Sequence AB
Participants received a single dose of midazolam 5 mg orally on Day 1 of Period 1 followed by a 2-day washout period. In Period 2, participants received PF-07817883 BID orally for 10 days followed by single dose of midazolam 5 mg on Day 10 followed by a washout of at least 7 days.
BG021
Part 5: Treatment Sequence BA
In Period 1, participants received PF-07817883 BID orally for 10 days and on Day 10, participants received a single oral dose of 5 mg midazolam administered with PF-07817883 followed by a washout of at least 7 days. In Period 2, participants received a single dose of midazolam 5 mg orally followed by a 2-day washout period.
BG022
Part 6: Treatment Sequence ABC
Participants received treatment A, B and C in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
BG023
Part 6: Treatment Sequence BCA
Participants received treatment B, C and A in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
BG024
Part 6: Treatment Sequence CAB
Participants received treatment C, A and B in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
BG025
Part 6: Treatment Sequence BAC
Participants received treatment B, A and C in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
BG026
Part 6: Treatment Sequence ACB
Participants received treatment A, C and B in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
BG027
Part 6: Treatment Sequence CBA
Participants received treatment C, B and A in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
BG028
Total
Total of all reporting groups
2
BG0012
BG0022
BG0032
BG0042
BG0052
BG0064
BG0076
BG0084
BG0094
BG0104
BG0111
BG0123
BG0132
BG0142
BG0152
BG0162
BG0172
BG0182
BG0196
BG0207
BG0217
BG0224
BG0234
BG0244
BG0254
BG0264
BG0274
BG02894
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18-44 Years
BG0000
BG0011
BG0021
BG0032
BG0041
BG0051
BG0062
BG0075
BG0082
BG0094
BG0102
BG0110
BG0123
BG0132
BG0140
BG0151
BG0161
BG0172
BG0182
BG0194
BG0204
BG0213
BG0223
BG0234
BG0244
BG0253
BG0263
BG0274
BG02864
45-60 Years
BG0002
BG0011
BG0021
BG0030
BG004
Not Disclosed
BG0000
BG0010
BG0020
BG0030
BG004
Sex/Gender, Customized
Data for arm - ''Part 2: Placebo (Suspension) BID, Fasted, Chinese'' is not disclosed to avoid risk of identification and kept under ''Not disclosed'' category.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG0021
BG0030
BG0041
BG0050
BG0061
BG0070
BG0080
BG0092
BG0100
BG0110
BG0120
BG0131
BG0140
BG0152
BG0161
BG0172
BG0180
BG0190
BG0202
BG0212
BG0220
BG0231
BG0241
BG0251
BG0260
BG0270
BG02819
Male
BG0001
BG0012
BG0021
BG0032
BG004
Not Disclosed
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Data for arm - ''Part 2: Placebo (Suspension) BID, Fasted, Chinese'' is not disclosed to avoid risk of identification and kept under ''Not disclosed'' category.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0231
BG0240
BG0250
BG0260
BG0270
BG0282
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0001
BG0011
BG0021
BG0031
BG004
White
BG0001
BG0011
BG0021
BG0031
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Not Disclosed
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Data for arm - ''Part 2: Placebo (Suspension) BID, Fasted, Chinese'' is not disclosed to avoid risk of identification and kept under ''Not disclosed'' category.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG0021
BG0031
BG0042
BG0051
BG0061
BG0074
BG0082
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0152
BG0161
BG0170
BG0180
BG0191
BG0203
BG0211
BG0220
BG0233
BG0242
BG0252
BG0262
BG0272
BG02833
Not Hispanic or Latino
BG0001
BG0011
BG0021
BG0031
BG004
Not Disclosed
BG0000
BG0010
BG0020
BG0030
BG004
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
Placebo (Suspension), Fed
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG002
PF-07817883 150 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG003
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG005
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG006
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG007
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG00010
OG0012
OG0026
OG0036
OG0044
OG0056
OG0065
OG0075
Title
Denominators
Categories
Title
Measurements
OG0004
OG0011
OG0022
OG0031
OG0040
OG0053
OG0060
OG0071
Primary
Part 1: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: (lymphocytes less than (<) 0.8*lower limit of normal [LLN] [10^3 per millimeter cube {mm3}], lymphocytes/leukocytes <0.8*LLN [percentage {%}], neutrophils <0.8*LLN [10^3/mm3], neutrophils/leukocytes <0.8*LLN [%], monocytes/leukocytes greater than (>) 1.2*upper limit of normal [ULN] [%], partial thromboplastin time >1.1*ULN [seconds]), chemistry (bicarbonate <0.9*LLN [milliequivalents per liter {mEq/L}], creatine kinase >2.0*ULN [units per liter {U/L}], lipase >1.5*ULN [U/L]), and urinalysis (urine hemoglobin greater than or equal to [>=] 1, leukocyte esterase >=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)
ID
Title
Description
OG000
Placebo (Suspension), Fasted
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
Placebo (Suspension), Fed
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG002
PF-07817883 150 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG003
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG005
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG006
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG007
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG00010
OG0012
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0005
OG0011
OG0022
OG003
Primary
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (<) 90 millimeter of mercury (mmHg), change greater than or equal to (>=) 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 beats per minute (bpm), value > 120 bpm.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 2 of each period
ID
Title
Description
OG000
Placebo (Suspension), Fasted
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
Placebo (Suspension), Fed
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG002
PF-07817883 150 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG003
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG005
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG006
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG007
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG00010
OG0012
OG0026
OG003
Title
Denominators
Categories
SBP value < 90 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1: Number of Participants With Electrocardiogram (ECG) Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 2 of each period
ID
Title
Description
OG000
Placebo (Suspension), Fasted
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
Placebo (Suspension), Fed
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG002
PF-07817883 150 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG003
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG005
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG006
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG007
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG00010
OG0012
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)
ID
Title
Description
OG000
Part 2: Placebo (Suspension) BID, Fasted
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
OG001
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG004
Part 2: Placebo (Suspension) BID, Fasted, Chinese
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
OG005
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0006
OG0014
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0020
OG003
Primary
Part 2: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (lymphocytes/leukocytes >1.2*ULN [%], neutrophils <0.8*LLN [10^3/mm3], neutrophils/leukocytes <0.8*LLN [%], monocytes/leukocytes >1.2*ULN [%]), chemistry (urate >1.2*ULN [milligrams per deciliter] {mg/dL}), and urinalysis (ketones >=1, urine hemoglobin >=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)
ID
Title
Description
OG000
Part 2: Placebo (Suspension) BID, Fasted
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
OG001
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG004
Part 2: Placebo (Suspension) BID, Fasted, Chinese
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
OG005
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0006
OG0014
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0022
OG003
Primary
Part 2: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 12
ID
Title
Description
OG000
Part 2: Placebo (Suspension) BID, Fasted
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
OG001
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG004
Part 2: Placebo (Suspension) BID, Fasted, Chinese
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
OG005
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0006
OG0014
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 2: Number of Participants With Electrocardiogram (ECG) Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 12
ID
Title
Description
OG000
Part 2: Placebo (Suspension) BID, Fasted
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
OG001
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG004
Part 2: Placebo (Suspension) BID, Fasted, Chinese
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
OG005
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0006
OG0014
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 3:Ratio Based on Area Under Plasma Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) and Area Under Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of Oral Formulation and Suspension
Data for AUClast and AUCinf are reported in the descriptive section. AUClast was calculated by the linear/log trapezoidal method. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. Ratio based on AUClast and AUCinf of oral formulation and suspension were reported in statistical analysis.
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
AUCinf
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG0026
ParticipantsOG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
AUCinf
Ratio of Adjusted Geometric Means
101.29
2-Sided
90
95.71
107.18
A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.
Other
Primary
Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Oral Formulation and Suspension
Data for Cmax are reported in the descriptive section. Ratio based on Cmax of oral formulation and suspension were reported in statistical analysis.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0009354± 18
OG0016934± 35
OG0024590± 21
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Ratio of Adjusted Geometric Means
67.18
2-Sided
90
58.13
77.65
A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.
Other
OG000
OG001
Primary
Part 4: Percentage of Total Dose Administered Recovered in Urine
The percentage of total dose administered recovered in urine was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Percentage dose excreted
Up to 144 hours post-dose
ID
Title
Description
OG000
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0004
Title
Denominators
Categories
Title
Measurements
OG00012.6± 4.7
Primary
Part 4: Percentage of Total Dose Administered Recovered in Feces
The percentage of total dose administered recovered in feces was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Percentage dose excreted
Up to 144 hours post-dose
ID
Title
Description
OG000
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0004
Title
Denominators
Categories
Title
Measurements
OG00088.9± 10
Primary
Part 4: Percentage of Total Dose Administered Recovered in Urine and Feces
The percentage of total dose administered recovered in urine and feces was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Percentage dose excreted
Up to 144 hours post-dose
ID
Title
Description
OG000
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0004
Title
Denominators
Categories
Title
Measurements
OG000101.5± 7.7
Primary
Part 5: Maximum Observed Concentration (Cmax) of Midazolam
Cmax of midazolam was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter (ng/mL)
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00012
OG00113
Title
Denominators
Categories
Title
Measurements
OG00033.71± 34
OG00130.20± 28
Primary
Part 5: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Midazolam
AUCinf of midazolam was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*Hour per milliliter (ng*hr/mL)
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00012
OG00113
Title
Denominators
Categories
Title
Measurements
OG00094.30± 26
OG00179.85± 31
Primary
Part 6: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)
ID
Title
Description
OG000
Placebo (Suspension), Fasted
Participants received Placebo oral suspension at 0 and 1 hours on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
OG001
PF-07817883 6000 mg (Suspension), Fasted
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
OG002
Moxifloxacin 400 mg, Fasted
Participants received 400 mg Moxifloxacin oral tablet and placebo at 0 and 1 hour respectively on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
Units
Counts
Participants
OG00023
OG00123
OG00224
Title
Denominators
Categories
Title
Measurements
OG0004
OG0016
OG0024
Primary
Part 6: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (lymphocytes <0.6*LLN [10^3/mm3], lymphocytes/leukocytes >1.2*ULN [%], neutrophils <0.8*LLN [10^3/mm3], neutrophils/leukocytes <0.8*LLN [%], basophils/leukocytes >1.2*ULN [%], eosinophils/leukocytes >1.2*ULN [%], monocytes/leukocytes >1.2*ULN [%], partial thromboplastin time >1.1*ULN [seconds], prothrombin time >1.1*ULN [seconds]), chemistry (bicarbonate <0.9*LLN [mEq/L], creatine kinase > 2.0*ULN [U/L], lipase > 1.5*ULN [U/L], urobilinogen >=1 [ehrlich units/deciliter] {EU/dL}) and urinalysis (urine hemoglobin >=1, leukocyte esterase >=1, ketones >=1, bacteria >20 [per low power field] {/lpf}). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)
ID
Title
Description
OG000
Placebo (Suspension), Fasted
Participants received Placebo oral suspension at 0 and 1 hours on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
OG001
PF-07817883 6000 mg (Suspension), Fasted
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
OG002
Moxifloxacin 400 mg, Fasted
Participants received 400 mg Moxifloxacin oral tablet and placebo at 0 and 1 hour respectively on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
Units
Counts
Participants
OG00023
OG00122
OG00224
Title
Denominators
Categories
Title
Measurements
OG00012
OG00112
OG0027
Primary
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 6 of each period
ID
Title
Description
OG000
Placebo (Suspension), Fasted
Participants received Placebo oral suspension at 0 and 1 hours on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
OG001
PF-07817883 6000 mg (Suspension), Fasted
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
OG002
Moxifloxacin 400 mg, Fasted
Participants received 400 mg Moxifloxacin oral tablet and placebo at 0 and 1 hour respectively on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
Units
Counts
Participants
OG00023
OG00123
OG00224
Title
Denominators
Categories
SBP value < 90 mmHg
Title
Measurements
OG0001
OG0012
OG0023
SBP change >= 30 mmHg increase
Primary
Part 6: Number of Participants According to Categorization of ECG Data
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured QTcF interval, aggregate 450 milliseconds (msec) < value <= 480 msec and QTcF interval, aggregate 30 msec < change <= 60 msec. Number of participants with abnormalities in ECG were reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 6 of each period
ID
Title
Description
OG000
Placebo (Suspension), Fasted
Participants received Placebo oral suspension at 0 and 1 hours on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
OG001
PF-07817883 6000 mg (Suspension), Fasted
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
OG002
Moxifloxacin 400 mg, Fasted
Participants received 400 mg Moxifloxacin oral tablet and placebo at 0 and 1 hour respectively on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
Units
Counts
Participants
OG00023
OG00123
OG00224
Title
Denominators
Categories
QTCF interval, aggregate 450 msec < Value <= 480 msec
Part 1: Maximum Observed Concentration (Cmax) of PF-07817883
Cmax of PF-07817883 was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0006
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0002269± 51
OG0016235± 20
OG0023223± 13
OG003
Secondary
Part 1: Time for Cmax (Tmax) of PF-07817883
Tmax of PF-07817883 was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0006
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.00(0.500 to 1.50)
OG0010.792(0.500 to 1.50)
OG0021.25(1.00 to 2.00)
OG003
Secondary
Part 1: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0006
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG00010890± 47
OG00134580± 25
OG00227080± 25
OG003
Secondary
Part 1: Dose Normalized Cmax (Cmax[dn]) of PF-07817883
Cmax(dn) of PF-07817883 was reported in this outcome measure. Cmax(dn) was calculated as Cmax/dose.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0006
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG00015.14± 51
OG00112.48± 19
OG0026.445± 13
OG003
Secondary
Part 1: Dose Normalized AUClast (AUClast[dn]) of PF-07817883
AUClast(dn) of PF-07817883 was reported in this outcome measure. AUClast(dn) was calculated by AUClast/dose.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0006
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG00072.61± 47
OG00169.17± 25
OG00254.16± 25
OG003
Secondary
Part 1: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0005
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG00011250± 53
OG00135950± 25
OG00228120± 28
OG003
Secondary
Part 1: Dose Normalized AUCinf (AUCinf[dn]) of PF-07817883
AUCinf(dn) of PF-07817883 was reported in this outcome measure. AUCinf(dn) was calculated as AUCinf/dose.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0005
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG00074.99± 53
OG00171.81± 25
OG00256.23± 28
OG003
Secondary
Part 1: Terminal Half-Life (t1/2) of PF-07817883
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0005
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.534± 0.50659
OG00113.88± 10.838
OG00215.95± 8.4657
OG003
Secondary
Part 1: Apparent Volume of Distribution (Vz/F) of PF-07817883
Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCinf*kel).
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0005
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG00086.87± 48
OG001209.5± 101
OG002366.1± 50
OG003
Secondary
Part 1: Apparent Clearance (CL/F) of PF-07817883
CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG001
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG002
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
OG003
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG004
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
OG005
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
Units
Counts
Participants
OG0005
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG00013.33± 53
OG00113.93± 25
OG00217.79± 28
OG003
Secondary
Part 2: Maximum Observed Concentration (Cmax) of PF-07817883 on Days 1, 5 and 10
Cmax of PF-07817883 was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram/milliliter
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Time for Cmax (Tmax) of PF-07817883 on Days 1, 5 and 10
Tmax of PF-07817883 was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Median
Full Range
Hours
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Area Under the Plasma Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) of PF-07817883 on Days 1, 5 and 10
AUCtau was defined as area under the plasma concentration-time profile from time 0 to time tau, the dosing interval, where tau= 12 hours. AUCtau of PF-07817883 was reported in this outcome measure. AUCtau was calculated by linear/log trapezoidal method.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter (ng*hr/mL)
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Concentration at 12 Hour Nominal Time Post-Dose (C12) of PF-07817883 on Days 5 and 10
C12 of PF-07817883 was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter (ng/mL)
12 hours on Day 5 and Day 10
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Dose Normalized Cmax (Cmax[dn]) of PF-07817883 on Days 1, 5 and 10
Cmax(dn) of PF-07817883 was reported in this outcome measure. Cmax(dn) was calculated as Cmax/dose.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram/milliliter/milligram (ng/mL/mg)
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Dose Normalized AUCtau (AUCtau[dn]) of PF-07817883 on Days 1, 5 and 10
AUCtau(dn) was defined as dose normalized AUCtau, where tau= 12 hours. AUCtau(dn) of PF-07817883 was reported in this outcome measure. AUCtau(dn) was calculated as AUCtau/dose.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour/milliliter/milligram
Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Average Concentration (Cav) of PF-07817883 on Days 5 and 10
Cav of PF-07817883 was reported in this outcome measure. Cav was calculated as AUCtau/12.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram/milliliter (ng/mL)
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Observed Accumulation Ratio for AUCtau (Rac) of PF-07817883 on Days 5 and 10
Rac was defined as observed accumulation ratio for AUCtau, where tau= 12 hours. Rac of PF-07817883 was reported in this outcome measure. Rac was calculated as AUCtau on Day 5 or Day 10/AUCtau on Day 1.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Observed Accumulation Ratio for Cmax (Rac,Cmax) of PF-07817883 on Days 5 and 10
Rac,Cmax of PF-07817883 was reported in this outcome measure. Rac,Cmax was calculated as Cmax on Day 5 or Day 10/Cmax on Day 1.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Peak-to-Trough Ratio (PTR) of PF-07817883 on Days 5 and 10
PTR of PF-07817883 was reported in this outcome measure. PTR was calculated as Cmax/Cmin.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Apparent Clearance (CL/F) of PF-07817883 on Days 5 and 10
CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter/hour (L/hr)
Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Secondary
Part 2: Apparent Volume of Distribution (Vz/F) of PF-07817883 on Day 10
Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau*kel).
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000200.1± 84
OG001279.6± 62
OG002198.1± 98
OG003
Secondary
Part 2: Terminal Half-Life (t1/2) of PF-07817883 on Day 10
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00013.95± 9.3938
OG00113.01± 8.8563
OG00211.44± 6.8367
OG003
Secondary
Part 2: Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of PF-07817883 on Day 10
Aetau was defined as amount excreted in urine as unchanged drug over the dosing interval tau, where tau= 12 hours. Aetau of PF-07817883 was reported in this outcome measure. Aetau was calculated as sum of (urine volume*urine concentration) for each collection over the dosing interval.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Milligram (mg)
Day 10 (0 to 12 hours)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG00018.47± 16
OG00196.86± 5
OG002373.2± 10
OG003
Secondary
Part 2: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of PF-07817883 on Day 10
Aetau% was defined as percentage of dose excreted in urine as unchanged drug over the dosing interval tau, where tau= 12 hours. Aetau% of PF-07817883 was reported in this outcome measure. Aetau% was calculated as 100*Aetau/dose.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Percentage of Dose Excreted
Day 10 (0 to 12 hours)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.261± 16
OG00116.15± 5
OG00224.90± 10
OG003
Secondary
Part 2: Renal Clearance (CLr) of PF-07817883 on Day 10
CLr of PF-07817883 was reported in this outcome measure. CLr was calculated as Aetau/AUCtau.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter/hour (L/hr)
Day 10 (0 to 12 hours)
ID
Title
Description
OG000
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
OG001
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
OG002
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
OG003
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.074± 20
OG0012.771± 5
OG0023.586± 26
OG003
Secondary
Part 3: Ratio Based on AUClast and AUCinf of Tablet Formulation Under Fed Condition and Fasted Condition
Data for AUClast and AUCinf are reported in the descriptive section. AUClast was calculated by the linear/log trapezoidal method. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. Ratio based on AUClast and AUCinf of tablet formulations under fed and fasted conditions were reported in statistical analysis.
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable for the specified rows. This outcome measure was planned to be analyzed only in the tablet formulation as pre-specified in the protocol.
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG002
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG0016
OG00212
OG003
Title
Denominators
Categories
AUCinf
ParticipantsOG00012
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
AUCinf
Ratio of Adjusted Geometric Means
72.87
2-Sided
90
60.98
87.09
A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages
Other
OG000
OG001
Secondary
Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Tablet Formulation Under Fed Condition and Fasted Condition
Data for Cmax are reported in the descriptive section. Ratio based on Cmax of tablet formulation under fed and fasted conditions were reported in statistical analysis.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. This outcome measure was planned to be analyzed only in the tablet formulation as pre-specified in the protocol.
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG002
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG0016
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG0006934± 35
OG0014590± 21
OG0026284± 38
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
Ratio of Adjusted Geometric Means
76.72
2-Sided
90
60.21
97.75
A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages
Other
OG000
OG001
Secondary
Part 3: Time for Cmax (Tmax) of PF-07817883
Tmax of PF-07817883 was reported in this outcome measure.
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.750(0.500 to 1.05)
OG0011.01(0.500 to 2.00)
OG0024.00(1.00 to 4.00)
OG003
Secondary
Part 3: Maximum Observed Concentration (Cmax) of PF-07817883
Cmax of PF-07817883 was reported in this outcome measure.
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0009354± 18
OG0016934± 35
OG0024590± 21
OG003
Secondary
Part 3: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00042540± 35
OG00143570± 37
OG00227750± 29
OG003
Secondary
Part 3: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00042970± 35
OG00144140± 38
OG00228430± 28
OG003
Secondary
Part 3: Terminal Half-Life (t1/2) of PF-07817883
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.578± 3.2536
OG0017.957± 3.8740
OG00210.15± 2.2890
OG003
Secondary
Part 3: Apparent Clearance (CL/F) of PF-07817883
CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00013.97± 35
OG00113.58± 38
OG00221.09± 28
OG003
Secondary
Part 3: Apparent Volume of Distribution (Vz/F) of PF-07817883
Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau*kel).
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000136.2± 55
OG001136.7± 50
OG002302.2± 31
OG003
Secondary
Part 3: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 days)
ID
Title
Description
OG000
Part 3: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0011
OG0021
OG003
Secondary
Part 3: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (monocytes/leukocytes >1.2*ULN [%], partial thromboplastin time >1.1*ULN [seconds]) and urinalysis (urine hemoglobin >=1, bacteria >20 [/lpf]). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 days)
ID
Title
Description
OG000
Part 3: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG003
Secondary
Part 3: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 3 of each period
ID
Title
Description
OG000
Part 3: PF-07817883 600 mg (Suspension), Fasted
Participants received PF-07817883 600 mg oral suspension under fasted conditions. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions. An overnight fast for approximately 10 hours was required. Participants swallowed PF-07817883 as whole and did not chew prior to swallowing.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack. Participants swallowed PF-07817883 as whole and did not chew prior to swallowing.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received PF-07817883 600 mg crystalline tablet under fasted conditions. An overnight fast for approximately 10 hours was required. Participants swallowed PF-07817883 as whole and did not chew prior to swallowing.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received PF-07817883 600 mg crystalline tablet under fed conditions. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack. Participants swallowed PF-07817883 as whole and did not chew prior to swallowing.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Part 3: Number of Participants With ECG Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 3 of each period
ID
Title
Description
OG000
Part 3: PF-07817883 600 mg (Suspension), Fasted
Participants received PF-07817883 600 mg oral suspension under fasted conditions. An overnight fast for approximately 10 hours was required.
OG001
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions. An overnight fast for approximately 10 hours was required. Participants swallowed PF-07817883 as whole and did not chew prior to swallowing.
OG002
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack. Participants swallowed PF-07817883 as whole and did not chew prior to swallowing.
OG003
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received PF-07817883 600 mg crystalline tablet under fasted conditions. An overnight fast for approximately 10 hours was required. Participants swallowed PF-07817883 as whole and did not chew prior to swallowing.
OG004
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received PF-07817883 600 mg crystalline tablet under fed conditions. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack. Participants swallowed PF-07817883 as whole and did not chew prior to swallowing.
Units
Counts
Participants
OG00012
OG00112
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Part 4: Time for Cmax (Tmax) of PF-07817883
Tmax of PF-07817883 was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0000.500(0.500 to 2.00)
Secondary
Part 4: Maximum Observed Concentration (Cmax) of PF-07817883
Cmax of PF-07817883 was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0006791± 35
Secondary
Part 4: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG00035520± 24
Secondary
Part 4: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG00036910± 26
Secondary
Part 4: Terminal Half-Life (t1/2) of PF-07817883
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG0006.882± 3.0621
Secondary
Part 4: Apparent Clearance (CL/F) of PF-07817883
CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG00016.26± 26
Secondary
Part 4: Apparent Volume of Distribution (Vz/F) of PF-07817883
Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau*kel).
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG000146.7± 36
Secondary
Part 4: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 days)
ID
Title
Description
OG000
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0004
Secondary
Part 4: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (mean corpuscular volume <0.9*LLN [cubic micrometer {um^3}], mean corpuscular hemoglobin <0.9*LLN [picograms per cell {pg/cell}], monocytes/leukocytes >1.2*ULN [%]). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 days)
ID
Title
Description
OG000
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0001
Secondary
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 11
ID
Title
Description
OG000
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
SBP value < 90 mmHg
Title
Measurements
OG0001
SBP change >= 30 mmHg increase
Title
Measurements
OG0000
SBP change >= 30 mmHg decrease
Secondary
Part 4: Number of Participants With ECG Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
Up to Day 11
ID
Title
Description
OG000
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0000
Secondary
Part 5: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00013
OG00113
Title
Denominators
Categories
Title
Measurements
OG00011
OG00110
Secondary
Part 5: Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included: hematology (lymphocytes <0.8*LLN [10^3/mm3], lymphocytes/leukocytes <0.8*LLN [%], neutrophils/leukocytes <0.8*LLN [%], monocytes/leukocytes >1.2*ULN [%]), chemistry (amylase >1.5*ULN [units/liter] {U/L}), and urinalysis (urine hemoglobin >=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00013
OG0017
Title
Denominators
Categories
Title
Measurements
OG0005
OG0012
Secondary
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; DBP: value < 50 mmHg, change >= 20 mmHg increase, change >= 20 mmHg decrease; PR: value < 40 bpm, value > 120 bpm.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00013
OG00113
Title
Denominators
Categories
SBP value < 90 mmHg
Title
Measurements
OG0003
OG0013
SBP change >= 30 mmHg increase
Title
Measurements
OG000
Secondary
Part 5: Number of Participants With ECG Abnormalities
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Posted
Count of Participants
Participants
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00013
OG00113
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Secondary
Part 5: Time for Cmax (Tmax) of Midazolam
Tmax of midazolam was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
Hours
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00012
OG00113
Title
Denominators
Categories
Title
Measurements
OG0000.500(0.500 to 1.12)
OG0010.500(0.500 to 1.02)
Secondary
Part 5: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam
AUClast of midazolam was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour/milliliter (ng*hr/mL)
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00012
OG00113
Title
Denominators
Categories
Title
Measurements
OG00092.37± 27
OG00177.46± 32
Secondary
Part 5: Terminal Half-Life (t1/2) of Midazolam
t1/2 of midazolam was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Hours
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00012
OG00113
Title
Denominators
Categories
Title
Measurements
OG0006.589± 1.6566
OG0016.923± 1.9185
Secondary
Part 5: Apparent Clearance (CL/F) of Midazolam
CL/F of midazolam was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter/hour
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00012
OG00113
Title
Denominators
Categories
Title
Measurements
OG00053.02± 26
OG00162.60± 31
Secondary
Part 5: Apparent Volume of Distribution (Vz/F) of Midazolam
Vz/F of midazolam was reported in this outcome measure. Vz/F was calculated as dose/(AUCinf*kel).
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
OG001
Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
Units
Counts
Participants
OG00012
OG00113
Title
Denominators
Categories
Title
Measurements
OG000488.5± 44
OG001598.9± 45
Secondary
Part 6: Maximum Observed Concentration (Cmax) of PF-07817883
Cmax of PF-07817883 was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
Units
Counts
Participants
OG00023
Title
Denominators
Categories
Title
Measurements
OG00053160± 21
Secondary
Part 6: Time for Cmax (Tmax) of PF-07817883
Tmax of PF-07817883 was reported in this outcome measure.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
Units
Counts
Participants
OG00023
Title
Denominators
Categories
Title
Measurements
OG0001.00(0.567 to 1.50)
Secondary
Part 6: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
Units
Counts
Participants
OG00023
Title
Denominators
Categories
Title
Measurements
OG000248300± 17
Secondary
Part 6: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Title
Measurements
OG000253000± 17
Secondary
Part 6: Terminal Half-Life (t1/2) of PF-07817883
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Title
Measurements
OG00012.64± 7.1787
0
10
0
10
4
10
EG001
Part 1: Placebo (Suspension), Fed
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
0
2
0
2
1
2
EG002
Part 1: PF-07817883 150 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
0
6
0
6
2
6
EG003
Part 1: PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
0
6
0
6
1
6
EG004
Part 1: PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
0
4
0
4
0
4
EG005
Part 1: PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
0
6
0
6
3
6
EG006
Part 1: PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
0
5
0
5
0
5
EG007
Part 1: PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
0
5
0
5
1
5
EG008
Part 2: Placebo (Suspension) BID, Fasted
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
0
6
0
6
2
6
EG009
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
0
4
0
4
1
4
EG010
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
0
4
0
4
0
4
EG011
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
0
4
0
4
2
4
EG012
Part 2: Placebo (Suspension) BID, Fasted, Chinese
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
0
1
0
1
0
1
EG013
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
0
3
0
3
2
3
EG014
Part 3: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
0
12
0
12
4
12
EG015
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
0
12
0
12
1
12
EG016
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
0
6
0
6
1
6
EG017
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
0
12
0
12
4
12
EG018
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
0
6
0
6
2
6
EG019
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
0
6
0
6
4
6
EG020
Part 5: PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
0
13
0
13
11
13
EG021
Part 5: Midazolam 5 mg
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
0
13
0
13
10
13
EG022
Part 6: Placebo (Suspension), Fasted
Participants received Placebo oral suspension at 0 and 1 hours on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
0
23
0
23
0
23
EG023
Part 6: PF-07817883 6000 mg (Suspension), Fasted
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
0
23
0
23
0
23
EG024
Part 6: Moxifloxacin 400 mg, Fasted
Participants received 400 mg Moxifloxacin oral tablet and placebo at 0 and 1 hour respectively on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
0
24
0
24
0
24
EG0002 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected4 at risk
EG0052 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0151 affected12 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Diarrhea
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0052 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Flatulence
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
COVID-19
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0211 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Nasopharyngitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0161 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0192 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Lipase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Urine output decreased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0131 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0181 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Headache
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0002 affected10 at risk
EG0010 affected2 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0141 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Defaecation urgency
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0131 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Glossodynia
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Nausea
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0081 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Vomiting
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0131 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Vessel puncture site bruise
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0111 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Oral herpes
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0081 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Pharyngitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Alanine aminotransferase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0111 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0191 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Hypoaesthesia
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0131 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Urinary retention
Renal and urinary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0081 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0081 affected6 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Pseudofolliculitis
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Haematoma
Vascular disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0132 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Haematochezia
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0141 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Fatigue
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0141 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0181 affected6 at risk
EG0190 affected6 at risk
EG0202 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Gastroenteritis viral
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0181 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0141 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0181 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Asthenia
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0191 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Urine output increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0191 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Syncope
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0191 affected6 at risk
EG0200 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Dizziness
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0202 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Paraesthesia
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Somnolence
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0209 affected13 at risk
EG0219 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0201 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0202 affected13 at risk
EG0210 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected4 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected5 at risk
EG0080 affected6 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0120 affected1 at risk
EG0130 affected3 at risk
EG0140 affected12 at risk
EG0150 affected12 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
EG0180 affected6 at risk
EG0190 affected6 at risk
EG0200 affected13 at risk
EG0211 affected13 at risk
EG0220 affected23 at risk
EG0230 affected23 at risk
EG0240 affected24 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
D014777
Virus Diseases
D018352
Coronavirus Infections
D003333
Coronaviridae Infections
D030341
Nidovirales Infections
D012327
RNA Virus Infections
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D006571
Heterocyclic Compounds
D024841
Fluoroquinolones
D042462
4-Quinolones
D015363
Quinolones
D011804
Quinolines
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
FG0260 subjects
FG0270 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0241 subjects
FG0250 subjects
FG0260 subjects
FG0270 subjects
1
BG0051
BG0062
BG0071
BG0082
BG0090
BG0102
BG0110
BG0120
BG0130
BG0142
BG0151
BG0161
BG0170
BG0180
BG0192
BG0203
BG0214
BG0221
BG0230
BG0240
BG0251
BG0261
BG0270
BG02829
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0281
1
BG0052
BG0063
BG0076
BG0084
BG0092
BG0104
BG0110
BG0123
BG0131
BG0142
BG0150
BG0161
BG0170
BG0182
BG0196
BG0205
BG0215
BG0224
BG0233
BG0243
BG0253
BG0264
BG0274
BG02874
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0281
0
BG0050
BG0060
BG0070
BG0080
BG0091
BG0102
BG0110
BG0123
BG0130
BG0140
BG0150
BG0161
BG0171
BG0180
BG0191
BG0202
BG0214
BG0221
BG0230
BG0241
BG0250
BG0261
BG0271
BG02819
1
BG0051
BG0062
BG0071
BG0083
BG0092
BG0101
BG0110
BG0120
BG0131
BG0140
BG0150
BG0161
BG0171
BG0181
BG0191
BG0202
BG0211
BG0222
BG0231
BG0241
BG0253
BG0260
BG0271
BG02831
1
BG0051
BG0062
BG0074
BG0081
BG0090
BG0101
BG0110
BG0120
BG0131
BG0142
BG0152
BG0160
BG0170
BG0181
BG0193
BG0203
BG0212
BG0221
BG0232
BG0242
BG0251
BG0263
BG0272
BG02839
0
BG0050
BG0060
BG0071
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0191
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0282
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0281
0
BG0051
BG0063
BG0072
BG0082
BG0094
BG0104
BG0110
BG0123
BG0132
BG0142
BG0150
BG0161
BG0172
BG0182
BG0195
BG0204
BG0216
BG0224
BG0231
BG0242
BG0252
BG0262
BG0272
BG02860
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0281
6
OG0044
OG0056
OG0065
OG0075
2
OG0041
OG0051
OG0062
OG0072
6
OG0044
OG0056
OG0065
OG0075
1
OG0041
OG0050
OG0061
OG0070
SBP Change >= 30 mmHg increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
SBP Change >= 30 mmHg decrease
Title
Measurements
OG0000
OG0010
OG0022
OG0031
OG0040
OG0050
OG0060
OG0070
DBP Value < 50 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
DBP Change >= 20 mmHg increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
DBP Change >= 20 mmHg decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
PR Value < 40 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
PR Value > 120 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
6
OG0044
OG0056
OG0065
OG0075
0
OG0040
OG0050
OG0060
OG0070
4
OG0041
OG0053
2
OG0040
OG0052
4
OG0041
OG0053
2
OG0040
OG0051
4
OG0041
OG0053
0
OG0040
OG0050
4
OG0041
OG0053
0
OG0040
OG0050
12
OG0046
11
ParticipantsOG0044
Title
Measurements
OG00042970± 35
OG00144140± 38
OG00228430± 28
OG00342930± 43
OG00446170± 27
AUClast
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG0026
ParticipantsOG00312
ParticipantsOG0046
Title
Measurements
OG00042540± 35
OG00143570± 37
OG00227750± 29
OG003
OG000
OG001
AUCinf
Ratio of Adjusted Geometric Means
102.74
2-Sided
90
97.28
108.50
A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.
Other
OG000
OG003
AUClast
Ratio of Adjusted Geometric Means
97.83
2-Sided
90
91.32
104.80
A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.
Other
OG000
OG001
AUClast
Ratio of Adjusted Geometric Means
102.41
2-Sided
90
95.60
109.70
A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.
Other
12
OG0046
6284
± 38
OG0045008± 47
Ratio of Adjusted Geometric Means
74.12
2-Sided
90
64.14
85.67
A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.
Other
Title
Measurements
OG0000
OG0011
OG0020
SBP change >= 30 mmHg decrease
Title
Measurements
OG0000
OG0010
OG0020
DBP value < 50 mmHg
Title
Measurements
OG0000
OG0010
OG0020
DBP change >= 20 mmHg increase
Title
Measurements
OG0000
OG0010
OG0020
DBP change >= 20 mmHg decrease
Title
Measurements
OG0000
OG0010
OG0021
Pulse rate value < 40 bpm
Title
Measurements
OG0000
OG0010
OG0020
Pulse rate value > 120 bpm
Title
Measurements
OG0000
OG0010
OG0020
Title
Measurements
OG0000
OG0010
OG0021
6
OG0045
OG0055
17420
± 36
OG00434420± 12
OG00534670± 36
6
OG0045
OG0055
0.500
(0.500 to 1.00)
OG0040.500(0.500 to 1.05)
OG0051.00(0.550 to 1.50)
6
OG0045
OG0055
83490
± 36
OG004160700± 33
OG005185700± 17
6
OG0045
OG0055
11.61
± 36
OG00411.49± 12
OG0058.672± 36
6
OG0045
OG0055
55.64
± 35
OG00453.53± 33
OG00546.43± 17
6
OG0045
OG0055
85320
± 34
OG004166100± 34
OG005189400± 19
6
OG0045
OG0055
56.86
± 34
OG00455.33± 35
OG00547.34± 19
6
OG0045
OG0055
10.84
± 6.1747
OG00418.79± 14.234
OG00513.05± 7.3974
6
OG0045
OG0055
242.9
± 80
OG004367.4± 87
OG005358.7± 44
6
OG0045
OG0055
17.58
± 35
OG00418.09± 35
OG00521.13± 19
3
3
Title
Measurements
OG0003582± 20
OG0018470± 39
OG00224100± 22
OG0038381± 12
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG0004234± 7
OG0019112± 14
OG00227530± 22
OG003
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG0003492± 15
OG0017852± 21
OG00223420± 14
OG003
3
3
Title
Measurements
OG0000.759(0.500 to 1.00)
OG0010.775(0.500 to 1.00)
OG0020.500(0.500 to 1.50)
OG0031.00(1.00 to 1.05)
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG0000.859(0.500 to 1.02)
OG0010.500(0.500 to 0.500)
OG0020.500(0.500 to 1.00)
OG003
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG0000.500(0.500 to 1.00)
OG0010.500(0.500 to 1.00)
OG0020.500(0.500 to 0.500)
OG003
3
3
Title
Measurements
OG00014760± 26
OG00136440± 27
OG002108400± 15
OG00336880± 22
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG00018460± 15
OG00136300± 10
OG002114000± 22
OG003
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG00017180± 10
OG00134960± 8
OG002103900± 18
OG003
3
3
Title
Measurements
OG000389.3± 15
OG001734.5± 15
OG0022598± 47
OG003716.0± 47
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG000425.7± 12
OG001865.9± 22
OG0022315± 35
OG003
3
3
Title
Measurements
OG00017.93± 20
OG00114.15± 39
OG00216.07± 22
OG00314.00± 12
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG00021.18± 7
OG00115.20± 13
OG00218.35± 22
OG003
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG00017.47± 15
OG00113.07± 21
OG00215.61± 14
OG003
3
3
Title
Measurements
OG00073.94± 26
OG00160.70± 27
OG00272.25± 15
OG00361.44± 22
Day 5
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG00092.46± 15
OG00160.49± 10
OG00276.20± 23
OG003
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG00086.04± 10
OG00158.28± 8
OG00269.43± 18
OG003
3
3
Title
Measurements
OG0001542± 15
OG0013022± 10
OG0029515± 22
OG0033140± 29
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG0001434± 10
OG0012914± 8
OG0028672± 18
OG003
3
3
Title
Measurements
OG0001.250± 28
OG0010.9972± 18
OG0021.054± 9
OG0031.022± 7
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG0001.163± 18
OG0010.8962± 20
OG0020.9605± 4
OG003
3
3
Title
Measurements
OG0001.183± 22
OG0011.075± 30
OG0021.142± 33
OG0030.9844± 18
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG0000.9744± 20
OG0010.8471± 36
OG0020.9717± 18
OG003
3
3
Title
Measurements
OG00010.88± 10
OG00113.47± 21
OG00210.60± 49
OG00313.22± 10
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG0008.566± 14
OG00111.05± 30
OG00210.13± 23
OG003
3
3
Title
Measurements
OG00010.83± 15
OG00116.57± 10
OG00213.12± 22
OG00315.88± 29
Day 10
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Title
Measurements
OG00011.60± 10
OG00117.13± 8
OG00214.37± 18
OG003
3
186.0
± 115
3
8.587
± 5.8524
3
85.85
± 20
3
14.34
± 20
3
2.477
± 51
6
4
Title
Measurements
OG00044140± 38
OG00128430± 28
OG00242930± 43
OG00346170± 27
AUClast
ParticipantsOG00012
ParticipantsOG0016
ParticipantsOG00212
ParticipantsOG0036
Title
Measurements
OG00043570± 37
OG00127750± 29
OG00241620± 41
OG003
AUCinf
Ratio of Adjusted Geometric Means
76.45
2-Sided
90
68.35
85.52
A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages
Other
OG000
OG001
AUClast
Ratio of Adjusted Geometric Means
73.52
2-Sided
90
65.70
82.27
A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages
Other
OG000
OG001
AUClast
Ratio of Adjusted Geometric Means
75.16
2-Sided
90
66.36
85.13
A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages
Other
6
5008
± 47
Ratio of Adjusted Geometric Means
70.92
2-Sided
90
53.70
93.67
A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages