A Study of PF-07258669 In Healthy Adult Participants | NCT05113940 | Trialant
NCT05113940
Sponsor
Pfizer
Status
Completed
Last Update Posted
Oct 24, 2024Actual
Enrollment
120Actual
Phase
Phase 1
Conditions
Healthy Participants
Interventions
PF-07258669
Placebo
Midazolam
Countries
Belgium
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05113940
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4541003
Secondary IDs
ID
Type
Description
Link
2021-004037-36
EudraCT Number
Brief Title
A Study of PF-07258669 In Healthy Adult Participants
Official Title
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACOKINETIC INTERACTION WITH MIDAZOLAM OF MULTIPLE ASCENDING ORAL DOSES OF PF-07258669 IN HEALTHY NON-JAPANESE AND JAPANESE ADULT PARTICIPANTS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jul 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 8, 2021Actual
Primary Completion Date
Jul 27, 2023Actual
Completion Date
Jul 27, 2023Actual
First Submitted Date
Oct 13, 2021
First Submission Date that Met QC Criteria
Oct 29, 2021
First Posted Date
Nov 9, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jul 24, 2024
Results First Submitted that Met QC Criteria
Jul 24, 2024
Results First Posted Date
Oct 24, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 24, 2024
Last Update Posted Date
Oct 24, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Part A of this study is to evaluate safety, tolerability, and pharmacokinetics (PK) of PF-07258669 after administration of multiple ascending oral doses to healthy adult participants. Optional cohorts of healthy adult Japanese participants and/or older adult participants may also be evaluated if results in other cohorts support further evaluation. Part B of this study is a 2-period, fixed-sequence, multiple-dose, open-label design to evaluate the effect of PF-07258669 on midazolam PK in healthy adult participants. Part B will be conducted if the results of Part A support further evaluation of PF-07258669.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy Participants
Keywords
PF-07258669
multiple dose
melanocortin-4 receptor
MC4R
healthy participants
safety
tolerability
pharmacokinetics
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
120Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-07258669 and Placebo (Cohort 1)
Experimental
Dose level 1: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: High Carbohydrate High Calorie (HCHC)
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 2)
Experimental
Dose level 2: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: HCHC
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 3)
Experimental
Dose level 3: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: HCHC
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 4)
Experimental
Dose level 4: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: Standard Diet (SD)
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 5)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-07258669
Drug
PF-07258669 will be administered as tablets; every 8 hour (Q8H) or every 12 hour (Q12H) over 14 days
Midazolam with and without PF-07258669 (Cohort 8)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) 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. TEAEs were events between first dose of study intervention and up to 35 days after last dose of study intervention that were absent before treatment or that worsened after treatment.
Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days)
Part A: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Laboratory assessments included clinical chemistry, hematology, and urinalysis. Abnormality was determined based on the criteria specified in the sponsor reporting standards. The primary criteria was less than (<) 0.8* lower limit of normal (LLN) for lymphocytes and lymphocytes/leukocytes, greater than (>) 1.2* upper limit of normal (ULN) for lymphocytes, eosinophils/leukocytes, monocytes, and monocytes/leukocytes; greater than (>) 3.0* ULN for alanine aminotransferase, >1.3* ULN for urea nitrogen, cholesterol, and triglycerides; >1.030 for specific gravity (scalar), greater than or equal to (>=) 1 for ketones, urine protein, urine hemoglobin, urine bilirubin, leukocyte esterase.
Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Vital signs included: a) supine systolic blood pressure (SBP): change greater than or equal to (>=) 30 millimeters of mercury (mmHg) increase, postural difference (supine standing) >= 20 mmHg, standing systolic SBP (mmHg) less than (<) 90 mmHg, >= 160 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; b) supine diastolic blood pressure (DBP) < 50 mmHg, >= 90 mmHg, change >= 20 mmHg increase, change >= 20mmHg decrease; postural difference (supine standing) >= 10 mmHg; standing <50 mmHg, value >=90 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease, C) standing pulse rate (PR) greater than (>) 140 bpm. Baseline for supine BP and pulse rate was defined as the average of the triplicate measurements collected at the pre-dose (0 hour) assessment on Day 1. Baseline for standing BP, standing pulse rate, respiratory rate and oral body temperature were defined as the pre-dose (0 hour) assessment on Day 1.
Secondary Outcomes
Measure
Description
Time Frame
Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07258669 on Days 1 and 14
Cmax was defined as the maximum plasma concentration.
Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14
Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax,dn) of PF-07258669 on Days 1 and 14
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For optional cohort of older adult participants only: Male participants and female participants of non childbearing potential must be 65 to 90 years of age, inclusive, at the time of signing the ICD (informed consent document). Attempts will be made to ensure that the age composition of this cohort (eg, approximately 70% of participants ≥70 years of age) is comparable to that of the anticipated patient population in later clinical studies.
Female participants of nonchildbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
For optional cohort of older adult participants only: Participants must be in a stable condition at admission. These participants must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination, vital signs assessments, 12-lead ECG (electrocardiogram), and clinical laboratory tests. Participants with mild, chronic, stable disease (eg, controlled hypertension, noninsulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator.
Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor and to wear eye protection, as appropriate.
Body mass index (BMI) of 17.5 to 28.5 kg/m2; and a total body weight >50 kg (110 lb).
For optional cohort of older adult participants only: BMI of 17.5 to 32.4 kg/m2; and a total body weight >50 kg (110 lbs). Efforts will be made to enroll at least 3 older adult participants with BMI <25 kg/m2, if feasible.
Japanese participants only: Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine (including, but not limited to, thyroid disease, diabetes insipidus), pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including, but not limited to, primary polydipsia, obsessive compulsive disorder, anxiety disorder, schizophrenia), neurological (including, but not limited to, seizure disorder, traumatic brain injury), immunodeficiency (including, but not limited to, severe infection that required ICU admission, prolonged hospitalization, or prolonged treatment) or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), as well as presence of clinical laboratory abnormalities.
For optional cohort of older adult participants only: Participants with chronic conditions (eg, hypertension) that are controlled by either diet or stable doses of medications may be included. Recent evidence (ie, within previous 6 months) or history of unstable disease or moderate to severe conditions which would, in the investigator's opinion, interfere with the study evaluations or have an impact on the safety of participants.
History of symptomatic orthostatic hypotension or symptomatic bradycardia.
History of eating disorders (eg, anorexia or bulimia nervosa, binge-eating disorder, avoidant/restrictive food intake disorder).
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.
For optional cohort of older adult participants only: Participants taking daily prescription or non-prescription medications (that are not moderate or strong cytochrome P450 (CYP3A) inducers or inhibitors) for management of acceptable chronic medical conditions are to be on a stable dose, as defined by no change in dose for the 28 days or 5 half-lives (whichever is longer) before the screening visit.
Use of stable concomitant mediations noted above that are CYP3A substrates may be restricted.
All medications must be reviewed on a case-by-case basis by the investigator and approved by the sponsor during the screening period for eligibility purposes.
Use of moderate or strong cytochrome P450 3A (CYP3A) inhibitors or inducers within 28 days or 5 half-lives (whichever is longer) prior to first dose of study intervention.
Previous administration with an investigational drug 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).
Fasting serum triglycerides >2× ULN (upper limit of normal).
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
60 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pfizer Clinical Research Unit - Brussels
Brussels
Bruxelles-capitale, Région de
B-1070
Belgium
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
Part A of this study was placebo-controlled evaluation of safety, tolerability, and PK of PF-07258669 after multiple ascending oral doses to healthy adult participants under 3 different dietary allocations: standard, high-carbohydrate high-calorie (HCHC), and high-fat, high-calorie (HFHC) diets. Part B was a 2-period, fixed-sequence, multiple-dose design to evaluate the effect of PF-07258669 on midazolam PK in healthy adult participants.
Recruitment Details
This study consisted of two parts: Part A and Part B. A total of 120 participants were enrolled in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
FG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
FG014
Midazolam Then PF-07258669 + Midazolam: Standard Diet
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 milligram (mg) oral solution on Day 1 of Period 1 and then oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Days 2 and 10 of Period 2, participants received midazolam 1 mg oral solution.
Periods
Title
Milestones
Reasons Not Completed
Part A (18 Days)
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0018 subjects
FG0028 subjects
FG0037 subjects
FG00410 subjects
FG0058 subjects
FG0068 subjects
FG0078 subjects
FG0088 subjects
FG0098 subjects
FG01012 subjects
FG01112 subjects
FG0121 subjects
FG0135 subjects
FG0140 subjects
COMPLETED
FG0006 subjects
FG0018 subjects
FG0027 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Part B- Period 1 (3 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsNo participants for Part B.
FG0010 subjectsNo participants for Part B.
FG0020 subjectsNo participants for Part B.
FG003
Part B- Period 2 (8 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Data cannot be reported in 'Placebo: Japanese 18-60 Years (Standard Diet)' reporting group due to risk of re-identification of the participant.
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) 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. TEAEs were events between first dose of study intervention and up to 35 days after last dose of study intervention that were absent before treatment or that worsened after treatment.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days)
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
Adverse Events Module
Frequency Threshold
5
Time Frame
Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Description
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neurological symptom
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
More Info Module
Limitations and Caveats
Any untoward findings identified on physical and/or neurological examinations, cardiac monitoring and pulse oximeter monitoring conducted during the active collection period were captured as adverse events, if those findings met the definition of an AE.
Dose level 5: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 6)
Experimental
Multiple dose administration of PF-07258669 and placebo over 14 days in Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD
Drug: PF-07258669
Drug: Placebo
Midazolam with and without PF-07258669 (Cohort 8)
Experimental
Drug-drug interaction assessment of pharmacokinetics interaction in PF-07258669 and midazolam Dietary allocation: SD
Drug: PF-07258669
Drug: Midazolam
PF-07258669 and Placebo (Cohort 7)
Experimental
Multiple dose administration of PF-07258669 and placebo over 14 days in older adult participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 9)
Experimental
Dose level 6: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 10)
Experimental
Dose level 7: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 11)
Experimental
Dose level 8: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 12)
Experimental
Dose Level 9: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: High Fat High Calorie (HFHC)
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 13)
Experimental
Dose Level 10: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: High Fat High Calorie (HFHC)
Drug: PF-07258669
Drug: Placebo
PF-07258669 and Placebo (Cohort 1)
PF-07258669 and Placebo (Cohort 10)
PF-07258669 and Placebo (Cohort 11)
PF-07258669 and Placebo (Cohort 12)
PF-07258669 and Placebo (Cohort 13)
PF-07258669 and Placebo (Cohort 2)
PF-07258669 and Placebo (Cohort 3)
PF-07258669 and Placebo (Cohort 4)
PF-07258669 and Placebo (Cohort 5)
PF-07258669 and Placebo (Cohort 6)
PF-07258669 and Placebo (Cohort 7)
PF-07258669 and Placebo (Cohort 9)
Placebo
Drug
Placebo will be administered as tablets; Q8H or Q12H over 14 days
PF-07258669 and Placebo (Cohort 1)
PF-07258669 and Placebo (Cohort 10)
PF-07258669 and Placebo (Cohort 11)
PF-07258669 and Placebo (Cohort 12)
PF-07258669 and Placebo (Cohort 13)
PF-07258669 and Placebo (Cohort 2)
PF-07258669 and Placebo (Cohort 3)
PF-07258669 and Placebo (Cohort 4)
PF-07258669 and Placebo (Cohort 5)
PF-07258669 and Placebo (Cohort 6)
PF-07258669 and Placebo (Cohort 7)
PF-07258669 and Placebo (Cohort 9)
Midazolam
Drug
Single doses of Midazolam will be administered as oral solution alone and in combination with PF-07258669
Midazolam with and without PF-07258669 (Cohort 8)
Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)
Part A: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria
ECG criteria: QTc corrected using Fridericia's formula (QTCF) interval aggregate in milliseconds (msec): less than or equal to (<=) change <= 60 msec. Baseline was defined as the average of the triplicate ECG measurements over the 3 pre-dose measurement times (-1 hour, -0.5 hour, and pre-dose 0 hour; total of 9 ECG measurements) on Day 1.
Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) at Screening
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day -2
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Part A: On Day -2 (2 days prior to dosing)
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 7
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Part A: On Day 7
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 14
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Part A: Day 14
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 21
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Part A: Day 21
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day at Screening
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by clinical research unit (CRU) staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day -1
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
Part A: Day -1 (1 day prior to dosing)
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 7
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
Part A: Day 7
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 14
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
Part A: Day 14
Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone on Day 1 of Period 1
Cmax was defined as the maximum observed plasma concentration.
Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1
Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 2 of Period 2
Cmax is the maximum observed plasma concentration.
Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2
Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 10 of Period 2
Cmax was defined as the maximum observed plasma concentration.
Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10
Part B: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam Alone on Day 1 of Period 1
AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1
Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 2 of Period 2
AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2
Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 10 of Period 2
AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10
Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUCinf) of Midazolam Alone on Day 1 of Period 1
AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1
Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 2 of Period 2
AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2
Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 10 of Period 2
AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10
Cmax was defined maximum observed serum concentration. Cmax (dn) was calculated as Cmax/dose.
Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (Tau) (AUCtau) of PF-07258669 on Days 1 and 14
Area under the plasma concentration-time profile from time zero to time tau, the dosing interval, where tau = 8 hours.
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14
Part A: Dose Normalized Area Under the Curve From Time 0 to Dosing Interval (Tau) (AUCtau, dn) of PF-07258669 on Days 1 and 14
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14
Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07258669 on Days 1 and 14
Tmax was defined as the time taken (in hours) to reach the maximum plasma drug concentration.
Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14
Part A: Amount of PF-0728669 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)
Aetau was defined as the amount of unchanged drug recovered in urine during the dosing interval.
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14
Part A: Percentage Dose of PF-07258669 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)
Aetau% was defined as the percentage of dose recovered in urine as unchanged drug.
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14
Part A: Renal Clearance (CLr) of PF-07258669
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14
Part B: Number of Participants With TEAEs
An AE 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. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment.
Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Part B: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Vital signs examination included: supine systolic blood pressure with criteria change >= 30 mmHg decrease, supine diastolic blood pressure with criteria value >= 90 mmHg and change >= 20 mmHg decrease.
Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)
Part B: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria
Following ECG parameters were analyzed: QTCF interval with criteria 450 less than (<) value less than or equal to (<=) 480. A standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QTc intervals and QRS complex. On Day 1 at -1 hour (h), -0.5h, and 0h prior to the morning dose, triplicate 12-lead ECGs were obtained approximately 2 to 4 minutes apart at each time point. The average of the triplicate ECG measurements over the 3 pre dose measurement times (total of 9 ECG measurements) collected before morning dose administration on Day 1 served as each participant's baseline QTc value.
Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)
Part B: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Laboratory parameters assessed included: hematology (monocytes, monocytes/leukocytes) with primary criteria greater than (>) 1.2*upper limit of normal (ULN), clinical chemistry (bilirubin, direct bilirubin and indirect bilirubin with primary criteria >1.5*ULN, alanine aminotransferase with primary criteria >3.0*ULN, creatine kinase with primary criteria >2.0*ULN, urobilinogen with primary criteria greater than or equal to (>=)1, cholesterol and triglycerides-fasting with primary criteria >1.3*ULN), urinalysis (ketones and urine hemoglobin with primary criteria >=1).
Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
9 subjects
FG0058 subjects
FG0068 subjects
FG0078 subjects
FG0088 subjects
FG0098 subjects
FG01012 subjects
FG01110 subjects
FG0121 subjects
FG0135 subjects
FG0140 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
1 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
No participants for Part B.
FG0040 subjectsNo participants for Part B.
FG0050 subjectsNo participants for Part B.
FG0060 subjectsNo participants for Part B.
FG0070 subjectsNo participants for Part B.
FG0080 subjectsNo participants for Part B.
FG0090 subjectsNo participants for Part B.
FG0100 subjectsNo participants for Part B.
FG0110 subjectsNo participants for Part B.
FG0120 subjectsNo participants for Part B.
FG0130 subjectsNo participants for Part B.
FG01411 subjectsParticipants enrolled in Part B of the study.
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
FG0120 subjects
FG0130 subjects
FG01411 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
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG01411 subjects
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
FG0120 subjects
FG0130 subjects
FG0149 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
FG0120 subjects
FG0130 subjects
FG0142 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0142 subjects
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
BG014
Midazolam Then PF-07258669 + Midazolam: Standard Diet
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 milligram (mg) oral solution on Day 1 of Period 1 and then oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Days 2 and 10 of Period 2, participants received midazolam 1 mg oral solution.
BG015
Total
Total of all reporting groups
6
BG0018
BG0028
BG0037
BG00410
BG0058
BG0068
BG0078
BG0088
BG0098
BG01012
BG01112
BG0121
BG0135
BG01411
BG015120
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18-44 Years
BG0002
BG0017
BG0027
BG0036
BG0047
BG0056
BG0065
BG0075
BG0086
BG0097
BG01010
BG01110
BG0120
BG0135
BG0149
BG01592
45-64 Years
BG0004
BG0011
BG0021
BG0031
BG004
Not disclosed
BG0000
BG0010
BG0020
BG0030
BG004
Sex/Gender, Customized
Data cannot be reported in 'Placebo: Japanese 18-60 Years (Standard Diet)' reporting group due to risk of re-identification of the participant.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0151
Male
BG0006
BG0018
BG0028
BG0037
BG004
Not disclosed
BG0000
BG0010
BG0020
BG0030
BG004
Ethnicity (NIH/OMB)
Data cannot be reported in 'Placebo: Japanese 18-60 Years (Standard Diet)' reporting group due to risk of re-identification of the participant.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG0021
BG0031
BG0040
BG0050
BG0060
BG0071
BG0083
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
BG0158
Not Hispanic or Latino
BG0006
BG0017
BG0027
BG0036
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Data cannot be reported in 'Placebo: Japanese 18-60 Years (Standard Diet)' reporting group due to risk of re-identification of the participant.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
Asian
BG0000
BG0011
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0011
BG0020
BG0031
BG004
White
BG0006
BG0016
BG0028
BG0036
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG0037
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
Title
Denominators
Categories
Title
Measurements
OG0005
OG0018
OG0026
OG0036
OG0049
OG0056
OG0067
OG0074
OG0087
OG0098
OG0108
OG01110
OG0120
OG0133
Primary
Part A: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Laboratory assessments included clinical chemistry, hematology, and urinalysis. Abnormality was determined based on the criteria specified in the sponsor reporting standards. The primary criteria was less than (<) 0.8* lower limit of normal (LLN) for lymphocytes and lymphocytes/leukocytes, greater than (>) 1.2* upper limit of normal (ULN) for lymphocytes, eosinophils/leukocytes, monocytes, and monocytes/leukocytes; greater than (>) 3.0* ULN for alanine aminotransferase, >1.3* ULN for urea nitrogen, cholesterol, and triglycerides; >1.030 for specific gravity (scalar), greater than or equal to (>=) 1 for ketones, urine protein, urine hemoglobin, urine bilirubin, leukocyte esterase.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0005
OG0016
OG0026
OG003
Primary
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Vital signs included: a) supine systolic blood pressure (SBP): change greater than or equal to (>=) 30 millimeters of mercury (mmHg) increase, postural difference (supine standing) >= 20 mmHg, standing systolic SBP (mmHg) less than (<) 90 mmHg, >= 160 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; b) supine diastolic blood pressure (DBP) < 50 mmHg, >= 90 mmHg, change >= 20 mmHg increase, change >= 20mmHg decrease; postural difference (supine standing) >= 10 mmHg; standing <50 mmHg, value >=90 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease, C) standing pulse rate (PR) greater than (>) 140 bpm. Baseline for supine BP and pulse rate was defined as the average of the triplicate measurements collected at the pre-dose (0 hour) assessment on Day 1. Baseline for standing BP, standing pulse rate, respiratory rate and oral body temperature were defined as the pre-dose (0 hour) assessment on Day 1.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Supine SBP Change >= 30mmHg increase
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Part A: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria
ECG criteria: QTc corrected using Fridericia's formula (QTCF) interval aggregate in milliseconds (msec): less than or equal to (<=) change <= 60 msec. Baseline was defined as the average of the triplicate ECG measurements over the 3 pre-dose measurement times (-1 hour, -0.5 hour, and pre-dose 0 hour; total of 9 ECG measurements) on Day 1.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG003
Primary
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) at Screening
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day -2
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: On Day -2 (2 days prior to dosing)
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 7
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: On Day 7
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 14
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: Day 14
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 21
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: Day 21
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day at Screening
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by clinical research unit (CRU) staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day -1
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: Day -1 (1 day prior to dosing)
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 7
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: Day 7
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 14
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Posted
Count of Participants
Participants
Part A: Day 14
ID
Title
Description
OG000
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0006
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone on Day 1 of Period 1
Cmax was defined as the maximum observed plasma concentration.
Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1
ID
Title
Description
OG000
Part B Period 1: Midazolam
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
Units
Counts
Participants
OG00011
Title
Denominators
Categories
Title
Measurements
OG0006.213± 43
Primary
Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 2 of Period 2
Cmax is the maximum observed plasma concentration.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2
ID
Title
Description
OG000
Part B Period 2: PF-07258669 + Midazolam (Day 2)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Days 2 and 10 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG00011
Title
Denominators
Categories
Title
Measurements
OG00010.83± 27
Primary
Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 10 of Period 2
Cmax was defined as the maximum observed plasma concentration.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10
ID
Title
Description
OG000
Part B Period 2: PF-07258669 + Midazolam (Day 10)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Day 10 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Title
Measurements
OG00011.73± 30
Primary
Part B: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam Alone on Day 1 of Period 1
AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter
Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1
ID
Title
Description
OG000
Part B Period 1: Midazolam
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
Units
Counts
Participants
OG00011
Title
Denominators
Categories
Title
Measurements
OG00018.56± 47
Primary
Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 2 of Period 2
AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter
Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2
ID
Title
Description
OG000
Part B Period 2: PF-07258669 + Midazolam (Day 2)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Day 2 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG00011
Title
Denominators
Categories
Title
Measurements
OG00030.27± 35
Primary
Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 10 of Period 2
AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter
Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10
ID
Title
Description
OG000
Part B Period 2: PF-07258669 + Midazolam (Day 10)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Day 10 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Title
Measurements
OG00040.41± 33
Primary
Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUCinf) of Midazolam Alone on Day 1 of Period 1
AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter
Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1
ID
Title
Description
OG000
Part B Period 1: Midazolam
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
Units
Counts
Participants
OG00010
Title
Denominators
Categories
Title
Measurements
OG00019.35± 48
Primary
Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 2 of Period 2
AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter
Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2
ID
Title
Description
OG000
Part B Period 2: PF-07258669 + Midazolam (Day 2)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Day 2 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG00010
Title
Denominators
Categories
Title
Measurements
OG00032.84± 32
Primary
Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 10 of Period 2
AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter
Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10
ID
Title
Description
OG000
Part B Period 2: PF-07258669 + Midazolam (Day 10)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Day 10 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Title
Measurements
OG00041.16± 34
Secondary
Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07258669 on Days 1 and 14
Cmax was defined as the maximum plasma concentration.
PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14
ID
Title
Description
OG000
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0008
OG0018
OG0027
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Secondary
Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax,dn) of PF-07258669 on Days 1 and 14
Cmax was defined maximum observed serum concentration. Cmax (dn) was calculated as Cmax/dose.
PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter per milligram
Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14
ID
Title
Description
OG000
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0008
OG0018
OG0027
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Secondary
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (Tau) (AUCtau) of PF-07258669 on Days 1 and 14
Area under the plasma concentration-time profile from time zero to time tau, the dosing interval, where tau = 8 hours.
PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms*hours per (/) milliliter
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14
ID
Title
Description
OG000
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0008
OG0018
OG0027
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Secondary
Part A: Dose Normalized Area Under the Curve From Time 0 to Dosing Interval (Tau) (AUCtau, dn) of PF-07258669 on Days 1 and 14
PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms*hours/ milliliter/ milligrams
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14
ID
Title
Description
OG000
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0008
OG0018
OG0027
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Secondary
Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07258669 on Days 1 and 14
Tmax was defined as the time taken (in hours) to reach the maximum plasma drug concentration.
PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Posted
Median
Full Range
Hours
Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14
ID
Title
Description
OG000
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0008
OG0018
OG0027
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Secondary
Part A: Amount of PF-0728669 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)
Aetau was defined as the amount of unchanged drug recovered in urine during the dosing interval.
PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Milligrams
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14
ID
Title
Description
OG000
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0008
OG0018
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.004304± 45
OG0010.004490± 153
OG0020.01690± 34
OG003
Secondary
Part A: Percentage Dose of PF-07258669 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)
Aetau% was defined as the percentage of dose recovered in urine as unchanged drug.
PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Percentage of dose
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14
ID
Title
Description
OG000
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0008
OG0018
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.2152± 45
OG0010.1496± 153
OG0020.2814± 34
OG003
Secondary
Part A: Renal Clearance (CLr) of PF-07258669
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).
PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter/ hour
Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14
ID
Title
Description
OG000
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG001
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG002
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG003
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG004
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG005
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG006
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG007
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG008
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
OG009
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
Units
Counts
Participants
OG0008
OG0018
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.06896± 37
OG0010.05887± 171
OG0020.1042± 44
OG003
Secondary
Part B: Number of Participants With TEAEs
An AE 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. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment.
The safety analysis set for Part B included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part B.
Posted
Count of Participants
Participants
Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
ID
Title
Description
OG000
Part B Period 1: Midazolam
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
OG001
Part B Period 2: PF-07258669 + Midazolam (Day 2)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 2 of Period 2, participants received midazolam 1 mg oral solution.
OG002
Part B Period 2: PF-07258669 + Midazolam (Day 10)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 10 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG00011
OG00111
OG0029
Title
Denominators
Categories
Title
Measurements
OG0002
OG0018
OG0022
Secondary
Part B: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Vital signs examination included: supine systolic blood pressure with criteria change >= 30 mmHg decrease, supine diastolic blood pressure with criteria value >= 90 mmHg and change >= 20 mmHg decrease.
The safety analysis set for Part B included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part B.
Posted
Count of Participants
Participants
Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)
ID
Title
Description
OG000
Part B Period 1: Midazolam
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
OG001
Part B Period 2: PF-07258669 + Midazolam (Day 2)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 2 of Period 2, participants received midazolam 1 mg oral solution.
OG002
Part B Period 2: PF-07258669 + Midazolam (Day 10)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 10 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG00011
OG00111
OG0029
Title
Denominators
Categories
Standing systolic blood pressure
Title
Measurements
OG0000
OG0011
OG0021
Standing diastolic blood pressure: value >= 90 mmHg
Secondary
Part B: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria
Following ECG parameters were analyzed: QTCF interval with criteria 450 less than (<) value less than or equal to (<=) 480. A standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QTc intervals and QRS complex. On Day 1 at -1 hour (h), -0.5h, and 0h prior to the morning dose, triplicate 12-lead ECGs were obtained approximately 2 to 4 minutes apart at each time point. The average of the triplicate ECG measurements over the 3 pre dose measurement times (total of 9 ECG measurements) collected before morning dose administration on Day 1 served as each participant's baseline QTc value.
The safety analysis set for Part B included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part B.
Posted
Count of Participants
Participants
Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)
ID
Title
Description
OG000
Part B Period 1: Midazolam
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
OG001
Part B Period 2: PF-07258669 + Midazolam (Day 2)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 2 of Period 2, participants received midazolam 1 mg oral solution
OG002
Part B Period 2: PF-07258669 + Midazolam (Day 10)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 10 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG00011
OG00111
OG0029
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
Secondary
Part B: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Laboratory parameters assessed included: hematology (monocytes, monocytes/leukocytes) with primary criteria greater than (>) 1.2*upper limit of normal (ULN), clinical chemistry (bilirubin, direct bilirubin and indirect bilirubin with primary criteria >1.5*ULN, alanine aminotransferase with primary criteria >3.0*ULN, creatine kinase with primary criteria >2.0*ULN, urobilinogen with primary criteria greater than or equal to (>=)1, cholesterol and triglycerides-fasting with primary criteria >1.3*ULN), urinalysis (ketones and urine hemoglobin with primary criteria >=1).
The safety analysis set for Part B included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part B.
Posted
Count of Participants
Participants
Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
ID
Title
Description
OG000
Part B Period 1: Midazolam
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
OG001
Part B Period 2: PF-07258669 + Midazolam (Day 2)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 2 of Period 2, participants received midazolam 1 mg oral solution.
OG002
Part B Period 2: PF-07258669 + Midazolam (Day 10)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 10 of Period 2, participants received midazolam 1 mg oral solution.
Units
Counts
Participants
OG00011
OG00111
OG0029
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG0024
0
6
0
6
5
6
EG001
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
8
0
8
8
8
EG002
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
8
1
8
6
8
EG003
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
7
0
7
6
7
EG004
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
10
0
10
9
10
EG005
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
8
0
8
6
8
EG006
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
8
0
8
7
8
EG007
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
8
0
8
4
8
EG008
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
8
0
8
7
8
EG009
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
8
0
8
8
8
EG010
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
12
0
12
8
12
EG011
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
12
0
12
10
12
EG012
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
1
0
1
0
1
EG013
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
0
5
0
5
3
5
EG014
Part B Period 1: Midazolam
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
0
11
0
11
2
11
EG015
Part B Period 2: PF-07258669 + Midazolam (Day 2)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 2 of Period 2, participants received midazolam 1 mg oral solution.
0
11
0
11
8
11
EG016
Part B Period 2: PF-07258669 + Midazolam (Day 10)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 10 of Period 2, participants received midazolam 1 mg oral solution.
0
9
0
9
2
9
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Atrial tachycardia
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Atrioventricular block first degree
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Nodal arrhythmia
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Nodal rhythm
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Palpitations
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Supraventricular extrasystoles
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Ear haemorrhage
Ear and labyrinth disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Hypoacusis
Ear and labyrinth disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Delayed light adaptation
Eye disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Eye haemorrhage
Eye disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Ocular discomfort
Eye disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Anal fissure
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0131 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Aphthous ulcer
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Change of bowel habit
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Constipation
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0053 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Dry mouth
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0072 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0092 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Flatulence
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0131 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Frequent bowel movements
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Lip dry
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0071 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Nausea
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Application site irritation
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0032 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Asthenia
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Chest discomfort
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Energy increased
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Facial pain
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Fatigue
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0003 affected6 at risk
EG0013 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0051 affected8 at risk
EG0060 affected8 at risk
EG0071 affected8 at risk
EG0081 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Feeling cold
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Feeling hot
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Hunger
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0074 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0152 affected11 at risk
EG0160 affected9 at risk
Influenza like illness
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Puncture site pain
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Thirst
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Vaccination site pain
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
COVID-19
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Folliculitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Hordeolum
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Influenza
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Nasopharyngitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0082 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Limb injury
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Scratch
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Wrist fracture
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Alanine aminotransferase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0152 affected11 at risk
EG0160 affected9 at risk
Heart rate increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Liver function test increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
SARS-CoV-2 test positive
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Food craving
Metabolism and nutrition disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0051 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Increased appetite
Metabolism and nutrition disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0131 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0051 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0042 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Dizziness
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Dizziness postural
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0131 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Dysgeusia
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Headache
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0031 affected7 at risk
EG0041 affected10 at risk
EG0051 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0161 affected9 at risk
Paraesthesia
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Parosmia
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Presyncope
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Somnolence
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0131 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Abnormal dreams
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Insomnia
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0093 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0141 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Nervousness
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Nightmare
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Poor quality sleep
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Restlessness
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Pollakiuria
Renal and urinary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0051 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0092 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0092 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0071 affected8 at risk
EG0081 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0042 affected10 at risk
EG0051 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0084 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0113 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0091 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Keratosis pilaris
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Scab
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0101 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0031 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Arrhythmia prophylaxis
Surgical and medical procedures
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Haematoma
Vascular disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0051 affected8 at risk
EG0060 affected8 at risk
EG0071 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0141 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Orthostatic hypotension
Vascular disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0061 affected8 at risk
EG0070 affected8 at risk
EG0081 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0111 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Vasoconstriction
Vascular disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0041 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Disturbance in attention
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0141 affected11 at risk
EG0150 affected11 at risk
EG0160 affected9 at risk
Drooling
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Micturition urgency
Renal and urinary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0151 affected11 at risk
EG0160 affected9 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected7 at risk
EG0040 affected10 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected1 at risk
EG0130 affected5 at risk
EG0140 affected11 at risk
EG0150 affected11 at risk
EG0161 affected9 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 publications 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.
D006571
Heterocyclic Compounds
3
BG0052
BG0063
BG0073
BG0082
BG0091
BG0102
BG0112
BG0120
BG0130
BG0142
BG01527
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0130
BG0140
BG0151
10
BG0058
BG0068
BG0078
BG0087
BG0098
BG01012
BG01112
BG0120
BG0135
BG01411
BG015118
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0130
BG0140
BG0151
10
BG0058
BG0068
BG0077
BG0085
BG0098
BG01011
BG01112
BG0120
BG0135
BG01410
BG015110
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0110
BG0121
BG0130
BG0140
BG0152
0
BG0050
BG0061
BG0070
BG0081
BG0090
BG0102
BG0110
BG0120
BG0135
BG0140
BG01510
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
3
BG0050
BG0061
BG0070
BG0080
BG0091
BG0103
BG0111
BG0120
BG0130
BG0141
BG01512
7
BG0058
BG0066
BG0078
BG0087
BG0097
BG0107
BG01111
BG0120
BG0130
BG01410
BG01597
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0130
BG0140
BG0151
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
6
OG0049
OG0055
OG0068
OG0077
OG0088
OG0094
OG01011
OG0118
OG0121
OG0133
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
SBP postural difference >=20mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0061
OG0071
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Standing SBP Value < 90 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0081
OG0090
OG0100
OG0111
OG0120
OG0130
Standing SBP Value >= 160 mmHg
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
OG0072
OG0080
OG0090
OG0101
OG0111
OG0120
OG0130
Standing SBP Value >= 30 mmHg increase
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0041
OG0050
OG0061
OG0071
OG0081
OG0092
OG0103
OG0113
OG0120
OG0131
Standing SBP Value >= 30 mmHg decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0111
OG0120
OG0130
Supine DBP Value >= 30 mmHg decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0111
OG0120
OG0130
Supine DBP value < 50 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
OG0130
Supine DBP value >= 90 mmHg
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Supine DBP change >= 20 mmHg increase
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Supine DBP change >= 20 mmHg decrease
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
DBP (mmHg) postural difference (supine standing)
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0072
OG0080
OG0090
OG0102
OG0110
OG0120
OG0130
Standing DBP value < 50 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Standing DBP value >= 90 mmHg
Title
Measurements
OG0002
OG0014
OG0021
OG0031
OG0043
OG0051
OG0063
OG0073
OG0081
OG0090
OG0103
OG0112
OG0120
OG0130
Standing DBP change >= 20 mmHg increase
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0061
OG0070
OG0081
OG0090
OG0102
OG0111
OG0120
OG0130
Standing diastolic BP change >= 20 mmHg decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0072
OG0081
OG0090
OG0101
OG0111
OG0121
OG0130
Standing PR >140 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0050
OG0060
OG0070
OG0081
OG0091
OG0100
OG0111
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0051
OG0060
OG0070
OG0081
OG0090
OG0100
OG0110
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
7
OG00410
OG0058
OG0068
OG0078
OG0088
OG0098
OG01012
OG01112
OG0121
OG0135
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
8
OG0048
OG0058
OG0068
OG0078
OG00812
OG0095
8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00812
ParticipantsOG0095
Title
Measurements
OG00019.47± 25
OG00125.06± 22
OG00250.41± 22
OG00345.99± 47
OG004131.2± 32
OG005468.3± 27
OG006987.2± 28
OG0071263± 37
OG0081218± 42
OG0091210± 9
Day 14
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00810
ParticipantsOG0095
Title
Measurements
OG00021.96± 21
OG00127.91± 25
OG00259.76± 29
OG003
8
OG0048
OG0058
OG0068
OG0078
OG00812
OG0095
8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00812
ParticipantsOG0095
Title
Measurements
OG0009.742± 25
OG0018.352± 22
OG0028.403± 22
OG0037.666± 47
OG0046.562± 32
OG0057.803± 27
OG0067.899± 28
OG0077.013± 37
OG0086.770± 42
OG0096.719± 9
Day 14
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00812
ParticipantsOG0095
Title
Measurements
OG00010.99± 22
OG0019.301± 25
OG0029.952± 29
OG003
8
OG0048
OG0058
OG0068
OG0078
OG00812
OG0095
8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00812
ParticipantsOG0095
Title
Measurements
OG00046.27± 26
OG00160.42± 27
OG002113.6± 15
OG003107.2± 42
OG004388.1± 38
OG0051207± 26
OG0062597± 29
OG0073357± 34
OG0083361± 27
OG0093331± 13
Day 14
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00810
ParticipantsOG0095
Title
Measurements
OG00062.40± 32
OG00176.25± 30
OG002162.0± 28
OG003
8
OG0048
OG0058
OG0068
OG0078
OG00812
OG0095
8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00812
ParticipantsOG0095
Title
Measurements
OG00023.16± 26
OG00120.15± 27
OG00218.93± 15
OG00317.87± 42
OG00419.42± 38
OG00520.14± 26
OG00620.75± 29
OG00718.64± 34
OG00818.67± 27
OG00918.52± 13
Day 14
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00810
ParticipantsOG0095
Title
Measurements
OG00031.21± 32
OG00125.44± 30
OG00227.01± 28
OG003
8
OG0048
OG0058
OG0068
OG0078
OG00812
OG0095
8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00812
ParticipantsOG0095
Title
Measurements
OG0001.000(0.500 to 1.50)
OG0011.000(0.500 to 1.05)
OG0020.5830(0.500 to 1.50)
OG0030.8265(0.500 to 1.13)
OG0041.010(0.500 to 2.00)
OG0051.000(0.500 to 1.50)
OG0061.000(0.500 to 1.50)
OG0071.000(1.00 to 1.05)
OG0081.000(0.550 to 1.50)
OG0090.5830(0.500 to 1.50)
Day 14
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG00810
ParticipantsOG0095
Title
Measurements
OG0001.010(0.500 to 1.52)
OG0011.000(0.500 to 1.02)
OG0020.7415(0.500 to 1.50)
OG003
8
OG0048
OG0058
OG0068
OG0078
OG00812
OG0095
0.01462
± 49
OG0040.04039± 70
OG0050.1440± 43
OG0060.3173± 109
OG0070.3371± 188
OG0080.3146± 314
OG0090.6581± 37
8
OG0048
OG0058
OG0068
OG0078
OG00812
OG0095
0.2436
± 49
OG0040.2020± 70
OG0050.2400± 43
OG0060.2536± 109
OG0070.1872± 189
OG0080.1748± 314
OG0090.3654± 37
8
OG0048
OG0058
OG0068
OG0078
OG00812
OG0095
0.09946
± 33
OG0040.08412± 48
OG0050.08026± 55
OG0060.08040± 116
OG0070.06341± 241
OG0080.05381± 350
OG0090.1083± 31
Title
Measurements
OG0000
OG0011
OG0021
Standing diastolic blood pressure: value change >= 20 mmHg decrease