A Study to Learn How Different Amounts of the Study Medic... | NCT06003777 | Trialant
NCT06003777
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jun 24, 2025Actual
Enrollment
26Actual
Phase
Phase 1
Conditions
Healthy Participants
Interventions
PF-06954522
Placebo
Countries
United States
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
NCT06003777
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4001001
Secondary IDs
ID
Type
Description
Link
NCT06003777
Registry Identifier
ClinicalTrials.gov
Brief Title
A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults
Official Title
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, CROSSOVER, FIRST-IN-HUMAN STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-06954522 IN HEALTHY ADULT PARTICIPANTS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jun 2025
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
Aug 30, 2023Actual
Primary Completion Date
Feb 20, 2024Actual
Completion Date
Feb 20, 2024Actual
First Submitted Date
Aug 3, 2023
First Submission Date that Met QC Criteria
Aug 15, 2023
First Posted Date
Aug 22, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Feb 19, 2025
Results First Submitted that Met QC Criteria
Jun 6, 2025
Results First Posted Date
Jun 24, 2025Actual
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
Jun 6, 2025
Last Update Posted Date
Jun 24, 2025Actual
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 purposes of this study are:
To see how the new medicine (PF-06954522) under study behave. And if there are any important side effects. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. The study will see how people feel after taking single increasing amount of the medicine by mouth.
To measure the amount of study medicine in your blood after the medicine is taken by mouth.
This study is seeking for participants who:
are females of 18 to 65 years old and are not able to give birth to a child.
are males of 18 to 65 years old.
have body mass index of 16 to 31 kilograms per meter squared.
have a total body weight of more than 50 kilograms (110 pounds).
Participants will be chosen by chance, like drawing names out of a hat to receive either:
study medicine (PF-06954522)
or placebo (a pill that has no medicine in it).
Participants may receive up to 4 amounts of study medicine and up to 2 amounts of placebo. The time frame of the study is approximately up to 36 days for each group and participants will stay at CRU for 20 days.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy Participants
Keywords
Not provided
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
26Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1
Experimental
Single dose administration of PF-06954522 and placebo. Participants will receive up to 5 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.
Drug: PF-06954522
Drug: Placebo
Cohort 2
Experimental
Single dose administration of PF-06954522 and placebo. Participants will receive up to 4 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.
Drug: PF-06954522
Drug: Placebo
Cohort 3
Experimental
Single dose administration of PF-06954522 and placebo. Participants will receive up to 2 dose levels of PF-06954522 and up to 1 dose level of matching placebo.
Drug: PF-06954522
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06954522
Drug
PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.
Cohort 1
Cohort 2
Cohort 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AEs) was any untoward medical occurrence in a participant or clinical study 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 start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With TEAEs
An AEs was any untoward medical occurrence in a participant or clinical study 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 start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With TEAEs
An AEs was any untoward medical occurrence in a participant or clinical study 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 start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Secondary Outcomes
Measure
Description
Time Frame
Cohort 1: Area Under the Plasma Concentration-Time Profile From Time Zero (0) to Time of Last Quantifiable Concentration (AUClast) of PF-06954522
AUClast was determined by using linear/log trapezoidal method.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: AUClast of PF-06954522
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
BMI of 16 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention, with the exception of moderate or strong cytochrome P450 3A (CYP3A) inducers or inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73 m².
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin
1.05 × upper limit of normal (ULN);
TSH > ULN;
HbA1c ≥6.5%;
Hematuria as defined by ≥1+ heme on urine dipstick;
Albuminuria as defined by urine albumin/creatinine ratio (UACR) >30 mg/g.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder 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
Pfizer Clinical Research Unit - New Haven
New Haven
Connecticut
06511
United States
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
In this study, dose have been reported from dose levels A to F, wherein Dose A is the lowest dose and Dose F is the highest dose received by study participants.
Recruitment Details
A total of 26 participants (initially randomized participants and replacement participants) were enrolled in this study. All participants received at least 1 dose of study intervention and were assigned in the study into 3 cohorts. As planned, there were "replacement" participants in the study who may or may not be required to complete all periods of the cohort in which they were participating at the discretion of the principal investigator and sponsor.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Sequence 1
Participants received PF-06954522 matching placebo on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 dose level D fed state high fat in Period 4 followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.
FG001
Cohort 1: Sequence 2
Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 matching placebo in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 matching placebo in Period 4 in fed state (high-fat meal) followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.
FG002
Cohort 1: Sequence 3
Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 matching placebo in Period 3, PF-06954522 dose level D fed state high fat in Period 4 followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.
FG003
Cohort 1: Sequence 4
Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 dose level D in Period 4 in fed state (high-fat meal) followed by PF-06954522 matching placebo in Period 5. There was a washout period of 7 days in between each period.
FG004
Cohort 1: Sequence 5
Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 dose level D fed state high fat in Period 4 followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.
FG005
Cohort 2: Sequence 1
Participants received PF-06954522 matching placebo on Day 1 Period 1 then PF-06954522 dose level A fed state standard meal in Period 2 then PF-06954522 dose level B fed state high fat meal in Period 3 followed by PF-06954522 dose level F in Period 4. There was a washout period of 7 days in between each period.
FG006
Cohort 2: Sequence 2
Participants received PF-06954522 dose level B on Day 1 Period 1 then PF-06954522 matching placebo in Period 2 in fed state (standard meal) then PF-06954522 matching placebo in Period 3 in fed state (high-fat meal) followed by PF-06954522 dose level F in Period 4. There was a washout period of 7 days in between each period.
FG007
Cohort 2: Sequence 3
Participants received PF-06954522 dose level B on Day 1 Period 1 then PF-06954522 dose level A fed state standard meal in Period 2 then PF-06954522 dose level B fed state high fat in Period 3 followed by PF-06954522 dose level F in Period 4. There was a washout period of 7 days in between each period.
FG008
Cohort 2: Sequence 4
Participants received PF-06954522 dose level B on Day 1 Period 1 then PF-06954522 dose level A fed state standard meal in Period 2 then PF-06954522 dose level B fed state high fat in Period 3 followed by PF-06954522 matching placebo in Period 4. There was a washout period of 7 days in between each period.
FG009
Cohort 3: Sequence 1
Japanese participants received PF-06954522 matching placebo on Day 1 Period 1 then PF-06954522 dose level E in Period 2 followed by PF-06954522 matching placebo in Period 3 in fed state (high-fat meal). There was a washout period of 7 days in between each period.
FG010
Cohort 3: Sequence 2
Japanese participants received PF-06954522 dose level D on Day 1 Period 1 then PF-06954522 matching placebo in Period 2 followed by PF-06954522 dose level D fed state high fat in Period 3. There was a washout period of 7 days in between each period.
FG011
Cohort 3: Sequence 3
Japanese participants received PF-06954522 dose level D on Day 1 Period 1 then PF-06954522 dose level E in Period 2 followed by PF-06954522 dose level D fed state high fat in Period 3. There was a washout period of 7 days in between each period.
Periods
Title
Milestones
Reasons Not Completed
Period 1
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
COMPLETED
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Period 2
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjectsParticipants may not have taken part in all study periods (including, for example, replacement participants). Therefore, the number of participants starting a period may not be equal to the number completing the previous period.
FG0022 subjectsParticipants may not have taken part in all study periods (including, for example, replacement participants). Therefore, the number of participants starting a period may not be equal to the number completing the previous period.
Period 3
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Period 4
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Period 5
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Data for baseline characteristics provided per cohort as prespecified in statistical analysis plan.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1
Participants received up to 5 dose levels of PF-06954522 and matching placebo.
BG001
Cohort 2
Participants received up to 4 dose levels of PF-06954522 and matching placebo.
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, Continuous
Mean
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
Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AEs) was any untoward medical occurrence in a participant or clinical study 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 start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
ID
Adverse Events Module
Frequency Threshold
5
Time Frame
From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3)
Description
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
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
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dry eye
Eye disorders
MedDRA v26.1
Non-systematic Assessment
More Info Module
Limitations and Caveats
Any untoward findings identified on physical examination and/or cardiac telemetry conducted during the active collection period were captured as adverse events, if those findings met the definition of an AE.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Name or Official Title: Pfizer ClinicalTrials.gov Call Center
Placebo will be administered as oral suspensions as escalating single doses to be determined.
Cohort 1
Cohort 2
Cohort 3
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg and increase or decrease from baseline >= 20mmHg.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
AUClast was determined by using linear/log trapezoidal method.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Maximum Observed Concentration (Cmax) of PF-06954522
Cmax of PF-06954522 was reported in this outcome measure.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: Cmax of PF-06954522
Cmax of PF-06954522 was reported in this outcome measure.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Time to Maximum Observed Concentration (Tmax) of PF-06954522
Tmax of PF-06954522 was reported in this outcome measure.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: Tmax of PF-06954522
Tmax of PF-06954522 was reported in this outcome measure.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of PF-06954522
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: AUCinf of PF-06954522
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Terminal Half-Life (t1/2) of PF-06954522
t1/2 was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: t1/2 of PF-06954522
t1/2was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
1 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0032 subjects
FG0042 subjectsParticipants may not have taken part in all study periods (including, for example, replacement participants). Therefore, the number of participants starting a period may not be equal to the number completing the previous period.
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0111 subjectsParticipants may not have taken part in all study periods (including, for example, replacement participants). Therefore, the number of participants starting a period may not be equal to the number completing the previous period.
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0081 subjects
FG0092 subjects
FG0102 subjects
FG0111 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
2 subjects
FG0042 subjects
FG0051 subjectsParticipants may not have taken part in all study periods (including, for example, replacement participants). Therefore, the number of participants starting a period may not be equal to the number completing the previous period.
FG0062 subjects
FG0072 subjects
FG0081 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjectsParticipants may not have taken part in all study periods (including, for example, replacement participants). Therefore, the number of participants starting a period may not be equal to the number completing the previous period.
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjectsThere was no period 4 in cohort 3.
FG0100 subjectsThere was no period 4 in cohort 3.
FG0110 subjectsThere was no period 4 in cohort 3.
COMPLETED
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
No longer met eligibility criteria
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
2 subjects
FG0042 subjects
FG0050 subjectsThere was no period 5 in cohort 2 or 3.
FG0060 subjectsThere was no period 5 in cohort 2 or 3.
FG0070 subjectsThere was no period 5 in cohort 2 or 3.
FG0080 subjectsThere was no period 5 in cohort 2 or 3.
FG0090 subjectsThere was no period 5 in cohort 2 or 3.
FG0100 subjectsThere was no period 5 in cohort 2 or 3.
FG0110 subjectsThere was no period 5 in cohort 2 or 3.
COMPLETED
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
BG002
Cohort 3
Participants received up to 3 dose levels of PF-06954522 and matching placebo.
BG003
Total
Total of all reporting groups
12
BG0018
BG0026
BG00326
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00043.6± 9.84
BG00142.1± 11.44
BG00242.5± 12.28
BG00342.9± 10.48
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0010
BG0020
BG0033
Male
BG0009
BG0018
BG0026
BG00323
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0015
BG0020
BG00310
Not Hispanic or Latino
BG0007
BG0013
BG0026
BG00316
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
Asian
BG0000
BG0011
BG0026
BG0037
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG0004
BG0013
BG0020
BG0037
White
BG0007
BG0013
BG0020
BG00310
More than one race
BG0001
BG0011
BG0020
BG0032
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal)
Participants received PF-06954522 dose level D in fed state with a high fat meal.
OG003
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG004
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
OG005
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG006
Cohort 1 and 2: Placebo (Fed State)
Participants received PF-06954522 matching placebo in fed state with high fat meal.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG0038
OG0046
OG00511
OG0064
Title
Denominators
Categories
Title
Measurements
OG0005
OG0018
OG0026
OG0038
OG0046
OG0053
OG0061
Primary
Cohort 2: Number of Participants With TEAEs
An AEs was any untoward medical occurrence in a participant or clinical study 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 start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
ID
Title
Description
OG000
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG001
Cohort 2: Placebo (Fed-standard Meal)
Participants received PF-06954522 matching placebo in the fed state standard-meal.
OG002
Cohort 1 and 2: Placebo (Fed-high Fat Meal)
Participants received PF-06954522 matching placebo in the fed state high-fat meal.
OG003
Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal)
Participants received PF-06954522 dose level A in the fed state standard-meal.
OG004
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG005
Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal)
Participants received PF-06954522 dose level B in the fed state high-fat meal.
OG006
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG00011
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0021
OG003
Primary
Cohort 3: Number of Participants With TEAEs
An AEs was any untoward medical occurrence in a participant or clinical study 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 start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
ID
Title
Description
OG000
Cohort 3: Placebo
Japanese participants received a single dose of matching placebo to PF-06954522 on Day 1 of Cohort 3.
OG001
Cohort 3: Placebo (Fed)
Japanese participants received a single dose of matching placebo to PF-06954522 in the fed state high-fat meal on Day 1 of Cohort 3.
OG002
Cohort 3: PF-06954522 Dose Level D
Japanese participants received PF-06954522 dose level D on Day 1 of Cohort 3.
OG003
Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal)
Japanese participants received PF-06954522 dose level D in the fed state high-fat meal on Day 1 of Cohort 3.
OG004
Cohort 3: PF-06954522 Dose Level E
Japanese participants received PF-06954522 dose level E on Day 1 of Cohort 3.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
OG0024
OG003
Primary
Cohort 1: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal
Participants received PF-06954522 dose level D in fed state with a high fat meal.
OG003
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG004
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
OG005
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG006
Cohort 1 and 2: Placebo (Fed State)
Participants received PF-06954522 matching placebo in fed state high fat meal.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0023
OG003
Primary
Cohort 2: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
ID
Title
Description
OG000
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG001
Cohort 2: Placebo (Fed-standard Meal)
Participants received PF-06954522 matching placebo in the fed standard-meal state.
OG002
Cohort 1 and 2: Placebo (Fed-high Fat Meal)
Participants received PF-06954522 matching placebo in the fed state high-fat meal.
OG003
Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal)
Participants received PF-06954522 dose level A in the fed state standard-meal.
OG004
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG005
Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal)
Participants received PF-06954522 dose level B in the fed state high-fat meal.
OG006
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG00011
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0011
OG0022
OG003
Primary
Cohort 3: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
ID
Title
Description
OG000
Cohort 3: Placebo
Japanese participants received a single dose of matching placebo to PF-06954522 on Day 1 of Cohort 3.
OG001
Cohort 3: Placebo (Fed)
Japanese participants received a single dose of matching placebo to PF-06954522 in the fed state high-fat meal on Day 1 of Cohort 3.
OG002
Cohort 3: PF-06954522 Dose Level D
Japanese participants received PF-06954522 dose level D on Day 1 of Cohort 3.
OG003
Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal)
Japanese participants received PF-06954522 dose level D in the fed state high-fat meal on Day 1 of Cohort 3.
OG004
Cohort 3: PF-06954522 Dose Level E
Japanese participants received PF-06954522 dose level E on Day 1 of Cohort 3.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Cohort 1: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal)
Participants received PF-06954522 dose level D in fed state with a high fat meal.
OG003
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG004
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
OG005
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG006
Cohort 1 and 2: Placebo (Fed State)
Participants received PF-06954522 matching placebo in fed state high fat meal.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Cohort 2: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
ID
Title
Description
OG000
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG001
Cohort 2: Placebo (Fed-standard Meal)
Participants received PF-06954522 matching placebo in the fed state standard-meal.
OG002
Cohort 1 and 2: Placebo (Fed-high Fat Meal)
Participants received PF-06954522 matching placebo in the fed state high-fat meal.
OG003
Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal)
Participants received PF-06954522 dose level A in the fed state standard-meal.
OG004
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG005
Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal)
Participants received PF-06954522 dose level B in the fed state high-fat meal.
OG006
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG00011
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0020
OG003
Primary
Cohort 3: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
ID
Title
Description
OG000
Cohort 3: Placebo
Japanese participants received a single dose of matching placebo to PF-06954522 on Day 1 of Cohort 3.
OG001
Cohort 3: Placebo (Fed)
Japanese participants received a single dose of matching placebo to PF-06954522 in the fed state high-fat meal on Day 1 of Cohort 3.
OG002
Cohort 3: PF-06954522 Dose Level D
Japanese participants received PF-06954522 dose level D on Day 1 of Cohort 3.
OG003
Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal)
Japanese participants received PF-06954522 dose level D in the fed state high-fat meal on Day 1 of Cohort 3.
OG004
Cohort 3: PF-06954522 Dose Level E
Japanese participants received PF-06954522 dose level E on Day 1 of Cohort 3.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG003
Primary
Cohort 1: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal)
Participants received PF-06954522 dose level D in fed state with a high fat meal.
OG003
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG004
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
OG005
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG006
Cohort 1 and 2: Placebo (Fed State)
Participants received PF-06954522 matching placebo in fed state high fat meal.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
OG0026
OG003
Primary
Cohort 2: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
ID
Title
Description
OG000
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG001
Cohort 2: Placebo (Fed-standard Meal)
Participants received PF-06954522 matching placebo in the fed state standard-meal.
OG002
Cohort 1 and 2: Placebo (Fed-high Fat Meal)
Participants received PF-06954522 matching placebo in the fed state high-fat meal.
OG003
Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal)
Participants received PF-06954522 dose level A in the fed state standard-meal.
OG004
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG005
Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal)
Participants received PF-06954522 dose level B in the fed state high-fat meal.
OG006
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG00011
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0005
OG0011
OG0022
OG003
Primary
Cohort 3: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
ID
Title
Description
OG000
Cohort 3: Placebo
Japanese participants received a single dose of matching placebo to PF-06954522 on Day 1 of Cohort 3.
OG001
Cohort 3: Placebo (Fed)
Japanese participants received a single dose of matching placebo to PF-06954522 in the fed state high-fat meal on Day 1 of Cohort 3.
OG002
Cohort 3: PF-06954522 Dose Level D
Japanese participants received PF-06954522 dose level D on Day 1 of Cohort 3.
OG003
Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal)
Japanese participants received PF-06954522 dose level D in the fed state high-fat meal on Day 1 of Cohort 3.
OG004
Cohort 3: PF-06954522 Dose Level E
Japanese participants received PF-06954522 dose level E on Day 1 of Cohort 3.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG003
Primary
Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal)
Participants received PF-06954522 dose level D in fed state with a high fat meal.
OG003
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG004
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
OG005
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG006
Cohort 1 and 2: Placebo (Fed State)
Participants received PF-06954522 matching placebo in fed state high fat meal.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Supine systolic blood pressure: Value < 90mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
ID
Title
Description
OG000
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG001
Cohort 2: Placebo (Fed-standard Meal)
Participants received PF-06954522 matching placebo in the fed state standard-meal.
OG002
Cohort 1 and 2: Placebo (Fed-high Fat Meal)
Participants received PF-06954522 matching placebo in the fed state high-fat meal.
OG003
Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal)
Participants received PF-06954522 dose level A in the fed state standard-meal.
OG004
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG005
Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal)
Participants received PF-06954522 dose level B in the fed state high-fat meal.
OG006
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG00011
OG0012
OG0024
OG003
Title
Denominators
Categories
Supine systolic blood pressure: Value < 90mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Cohort 3: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg and increase or decrease from baseline >= 20mmHg.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
ID
Title
Description
OG000
Cohort 3: Placebo
Japanese participants received a single dose of matching placebo to PF-06954522 on Day 1 of Cohort 3.
OG001
Cohort 3: Placebo (Fed)
Japanese participants received a single dose of matching placebo to PF-06954522 in the fed state high-fat meal on Day 1 of Cohort 3.
OG002
Cohort 3: PF-06954522 Dose Level D
Japanese participants received PF-06954522 dose level D on Day 1 of Cohort 3.
OG003
Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal)
Japanese participants received PF-06954522 dose level D in the fed state high-fat meal on Day 1 of Cohort 3.
OG004
Cohort 3: PF-06954522 Dose Level E
Japanese participants received PF-06954522 dose level E on Day 1 of Cohort 3.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG003
Title
Denominators
Categories
Supine systolic blood pressure: Value < 90mmHg
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal)
Participants received PF-06954522 dose level D in fed state with a high fat meal.
OG003
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG004
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
OG005
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG006
Cohort 1 and 2: Placebo (Fed State)
Participants received PF-06954522 matching placebo in fed state high fat meal.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
PR interval: value >=300
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
ID
Title
Description
OG000
Cohort 1 and 2: Placebo (Fasted State)
Participants received PF-06954522 matching placebo in fasted state.
OG001
Cohort 2: Placebo (Fed-standard Meal)
Participants received PF-06954522 matching placebo in the fed state standard-meal.
OG002
Cohort 1 and 2: Placebo (Fed-high Fat Meal)
Participants received PF-06954522 matching placebo in the fed state high-fat meal.
OG003
Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal)
Participants received PF-06954522 dose level A in the fed state standard-meal.
OG004
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG005
Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal)
Participants received PF-06954522 dose level B in the fed state high-fat meal.
OG006
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG00011
OG0012
OG0024
OG003
Title
Denominators
Categories
PR interval: value >=300
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
ID
Title
Description
OG000
Cohort 3: Placebo
Japanese participants received a single dose of matching placebo to PF-06954522 on Day 1 of Cohort 3.
OG001
Cohort 3: Placebo (Fed)
Japanese participants received a single dose of matching placebo to PF-06954522 in the fed state high-fat meal on Day 1 of Cohort 3.
OG002
Cohort 3: PF-06954522 Dose Level D
Japanese participants received PF-06954522 dose level D on Day 1 of Cohort 3.
OG003
Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal)
Japanese participants received PF-06954522 dose level D in the fed state high-fat meal on Day 1 of Cohort 3.
OG004
Cohort 3: PF-06954522 Dose Level E
Japanese participants received PF-06954522 dose level E on Day 1 of Cohort 3.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG003
Title
Denominators
Categories
PR interval: value >=300
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Cohort 1: Area Under the Plasma Concentration-Time Profile From Time Zero (0) to Time of Last Quantifiable Concentration (AUClast) of PF-06954522
AUClast was determined by using linear/log trapezoidal method.
Pharmacokinetic (PK) parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter (ng*hr/mL)
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG003
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001394± 37
OG0014252± 43
OG0027503± 60
OG003
Secondary
Cohort 2: AUClast of PF-06954522
AUClast was determined by using linear/log trapezoidal method.
PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG001
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0006
OG0015
Title
Denominators
Categories
Title
Measurements
OG000827.2± 24
OG00112630± 40
Secondary
Cohort 1: Maximum Observed Concentration (Cmax) of PF-06954522
Cmax of PF-06954522 was reported in this outcome measure.
PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter (ng/mL)
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG003
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG000112.9± 40
OG001377.7± 38
OG002837.6± 53
OG003
Secondary
Cohort 2: Cmax of PF-06954522
Cmax of PF-06954522 was reported in this outcome measure.
PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG001
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0006
OG0015
Title
Denominators
Categories
Title
Measurements
OG00086.82± 28
OG0011088± 57
Secondary
Cohort 1: Time to Maximum Observed Concentration (Tmax) of PF-06954522
Tmax of PF-06954522 was reported in this outcome measure.
PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).
Posted
Median
Full Range
Hours
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG003
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.02(1.00 to 2.00)
OG0013.00(1.02 to 12.0)
OG0022.02(1.00 to 6.00)
OG003
Secondary
Cohort 2: Tmax of PF-06954522
Tmax of PF-06954522 was reported in this outcome measure.
PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).
Posted
Median
Full Range
Hours
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG001
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0006
OG0015
Title
Denominators
Categories
Title
Measurements
OG0002.04(1.00 to 4.05)
OG0011.00(0.600 to 4.00)
Secondary
Cohort 1: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of PF-06954522
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.
PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter (ng.hr/mL)
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG003
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001415± 36
OG0014283± 43
OG0027576± 60
OG003
Secondary
Cohort 2: AUCinf of PF-06954522
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.
PK parameter set: all participants who were randomly assigned to study intervention & received at least 1 dose of study intervention & had at least 1 of PK parameters of interest calculated. "Overall Number of Participants Analyzed" signifies participants evaluable for this parameter. Data for cohorts and periods included in pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in fasted state).
Posted
Geometric Mean
Geometric Coefficient of Variation
ng.hr/mL
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG001
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0006
OG0015
Title
Denominators
Categories
Title
Measurements
OG000846.6± 23
OG00112700± 40
Secondary
Cohort 1: Terminal Half-Life (t1/2) of PF-06954522
t1/2 was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).
Posted
Mean
Standard Deviation
Hours
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
OG001
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
OG002
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
OG003
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.313± 1.4278
OG0018.444± 3.3668
OG0027.264± 2.8676
OG003
Secondary
Cohort 2: t1/2 of PF-06954522
t1/2was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
PK parameter set: all participants who were randomly assigned to study intervention & received at least 1 dose of study intervention & had at least 1 of PK parameters of interest calculated. "Overall Number of Participants Analyzed" signifies participants evaluable for this parameter. Data for cohorts and periods included in pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in fasted state).
Posted
Mean
Standard Deviation
Hours
From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
ID
Title
Description
OG000
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
OG001
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
Units
Counts
Participants
OG0006
OG0015
Title
Denominators
Categories
Title
Measurements
OG0005.918± 0.74714
OG0017.766± 2.6585
0
11
0
11
3
11
EG001
Cohort 1 and 2: Placebo (Fed State)
Participants received PF-06954522 matching placebo in fed state high fat meal.
0
4
0
4
1
4
EG002
Cohort 1: PF-06954522 Dose Level C
Participants received PF-06954522 dose level C in fasted state.
0
7
0
7
5
7
EG003
Cohort 1: PF-06954522 Dose Level D
Participants received PF-06954522 dose level D in fasted state.
0
8
0
8
8
8
EG004
Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal)
Participants received PF-06954522 dose level D in fed state with a high fat meal.
0
8
0
8
6
8
EG005
Cohort 1: PF-06954522 Dose Level E
Participants received PF-06954522 dose level E in fasted state.
0
8
0
8
8
8
EG006
Cohort 1: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
0
6
0
6
6
6
EG007
Cohort 2: Placebo Standard Meal
Participants received PF-06954522 matching placebo in the standard meal.
0
2
0
2
0
2
EG008
Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal)
Participants received PF-06954522 dose level A in the fed state standard-meal.
0
6
0
6
2
6
EG009
Cohort 2: PF-06954522 Dose Level B
Participants received PF-06954522 dose level B in fasted state.
0
6
0
6
2
6
EG010
Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal)
Participants received PF-06954522 dose level B in the fed state high-fat meal.
0
4
0
4
0
4
EG011
Cohort 2: PF-06954522 Dose Level F
Participants received PF-06954522 dose level F in fasted state.
0
5
0
5
5
5
EG012
Cohort 3: Placebo
Japanese participants received a single dose of matching placebo of PF-06954522 on Day 1 of Cohort 3.
0
4
0
4
3
4
EG013
Cohort 3: Placebo (Fed)
Japanese participants received a single dose of matching placebo to PF-06954522 in the fed state high-fat meal on Day 1 of Cohort 3.
0
2
0
2
2
2
EG014
Cohort 3: PF-06954522 Dose Level D
Japanese participants received PF-06954522 dose level D on Day 1 of Cohort 3.
0
4
0
4
4
4
EG015
Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal)
Japanese participants received PF-06954522 dose level D in the fed state high-fat meal on Day 1 of Cohort 3.
0
4
0
4
4
4
EG016
Cohort 3: PF-06954522 Dose Level E
Japanese participants received PF-06954522 dose level E on Day 1 of Cohort 3.
0
3
0
3
3
3
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Extraocular muscle disorder
Eye disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected4 at risk
EG0111 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0001 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Constipation
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0031 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
EG0141 affected4 at risk
EG0151 affected4 at risk
EG0160 affected3 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0151 affected4 at risk
EG0160 affected3 at risk
Faeces soft
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0161 affected3 at risk
Flatulence
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0111 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0062 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0141 affected4 at risk
EG0150 affected4 at risk
EG0161 affected3 at risk
Nausea
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0023 affected7 at risk
EG0036 affected8 at risk
EG0045 affected8 at risk
EG0054 affected8 at risk
EG0064 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected4 at risk
EG0113 affected5 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
EG0143 affected4 at risk
EG0153 affected4 at risk
EG0162 affected3 at risk
Vomiting
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG0035 affected8 at risk
EG0044 affected8 at risk
EG0057 affected8 at risk
EG0064 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected4 at risk
EG0114 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0144 affected4 at risk
EG0153 affected4 at risk
EG0162 affected3 at risk
Chills
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0111 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0162 affected3 at risk
Early satiety
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0161 affected3 at risk
Fatigue
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0052 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0161 affected3 at risk
Pain
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Pyrexia
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0041 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0151 affected4 at risk
EG0160 affected3 at risk
Pharyngitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0131 affected2 at risk
EG0140 affected4 at risk
EG0151 affected4 at risk
EG0160 affected3 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0131 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Lip injury
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0031 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Scratch
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Wound
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Pancreatic enzymes increased
Investigations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0111 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Transaminases increased
Investigations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Urine amphetamine positive
Investigations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0041 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0032 affected8 at risk
EG0041 affected8 at risk
EG0053 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0112 affected5 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0152 affected4 at risk
EG0161 affected3 at risk
Food craving
Metabolism and nutrition disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0031 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Brain fog
Nervous system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0161 affected3 at risk
Dizziness
Nervous system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0031 affected8 at risk
EG0040 affected8 at risk
EG0051 affected8 at risk
EG0061 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0142 affected4 at risk
EG0151 affected4 at risk
EG0161 affected3 at risk
Headache
Nervous system disorders
MedDRA v26.1
Non-systematic Assessment
EG0001 affected11 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG0033 affected8 at risk
EG0043 affected8 at risk
EG0055 affected8 at risk
EG0063 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected4 at risk
EG0112 affected5 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
EG0144 affected4 at risk
EG0154 affected4 at risk
EG0163 affected3 at risk
Paraesthesia
Nervous system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0031 affected8 at risk
EG0041 affected8 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0113 affected5 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
EG0141 affected4 at risk
EG0151 affected4 at risk
EG0162 affected3 at risk
Somnolence
Nervous system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG0031 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Tremor
Nervous system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Pollakiuria
Renal and urinary disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0111 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0041 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0031 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0001 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0033 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0081 affected6 at risk
EG0091 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0141 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0001 affected11 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected5 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
EG0140 affected4 at risk
EG0150 affected4 at risk
EG0160 affected3 at risk
Restriction Type
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.
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
6
OG0046
OG0054
OG0065
2
OG0042
OG0050
OG0065
4
OG0043
4
OG0043
8
OG0046
OG00511
OG0064
2
OG0041
OG0053
OG0062
6
OG0046
OG0054
OG0065
3
OG0042
OG0051
OG0064
4
OG0043
0
OG0040
8
OG0046
OG00511
OG0064
2
OG0040
OG0053
OG0060
6
OG0046
OG0054
OG0065
2
OG0041
OG0050
OG0062
4
OG0043
1
OG0040
8
OG0046
OG00511
OG0064
3
OG0043
OG0055
OG0062
6
OG0046
OG0054
OG0065
2
OG0045
OG0051
OG0063
4
OG0043
1
OG0041
8
OG0046
OG00511
OG0064
0
OG0040
OG0050
OG0060
Supine systolic blood pressure : Increase from baseline >= 30mmHg
Title
Measurements
OG0001
OG0011
OG0020
OG0033
OG0041
OG0050
OG0060
Supine diastolic blood pressure: Increase from baseline >= 20mmHg
Title
Measurements
OG0000
OG0013
OG0020
OG0034
OG0040
OG0050
OG0060
Supine pulse rate: Value > 120bpm
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
6
OG0046
OG0054
OG0065
1
OG0040
OG0051
OG0060
Supine systolic blood pressure : Increase from baseline >= 30mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
Supine diastolic blood pressure: Increase from baseline >= 20mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0063
Supine pulse rate: Value > 120bpm
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
4
OG0043
0
OG0041
Supine systolic blood pressure : Increase from baseline >= 30mmHg
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0042
Supine diastolic blood pressure: Increase from baseline >= 20mmHg
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
8
OG0046
OG00511
OG0064
0
OG0040
OG0050
OG0060
PR interval: baseline > 200 and % change >=25%
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
PR interval: baseline <=200 and percentage change >=50%
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QRS duration: value >=140
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QRS duration: % change>= 50%
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QTcF: 450 < value <= 480
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
QTcF: 480<= value <500
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QTcF: value >=500
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QTcF: 30<= change <60
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QTcF: change >60
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
6
OG0046
OG0054
OG0065
0
OG0040
OG0050
OG0060
PR interval: baseline > 200 and % change >=25%
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
PR interval: baseline <=200 and percentage change >=50%
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QRS duration: value >=140
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QRS duration: % change>= 50%
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QTcF: 450 < value <= 480
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QTcF: 480<= value <500
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QTcF: value >=500
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QTcF: 30<= change <60
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
QTcF: change >60
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
4
OG0043
0
OG0040
PR interval: baseline > 200 and % change >=25%
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
PR interval: baseline <=200 and percentage change >=50%