Trial Outcomes & Findings for Study in Healthy Adults Evaluating PF-07202954 (NCT NCT04857437)

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were AEs that occurred following the start of study treatment (either PF-07202954 or placebo) up to approximately 28 days after the last dose.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

Results posted on

2024-09-20

Participant Flow

Study originally had 3 parts. Sponsor strategically decided not to conduct Part 2 and 3, based on results from Part 1 of the study. This decision was not due to any safety concern from Part 1 of the study. The study was concluded following Part 1; hence, no participants were enrolled in Part 2 and 3.

Participant milestones

Participant milestones
Measure	Part1 Cohort1: Placebo/PF-07202954 100mg Std Meal/PF-07202954 600mg/PF-07202954 100mg High Fat Meal Participants were administered a single oral dose of placebo with a standard (std) meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 100 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 600 mg with a std meal and PF-07202954 100 mg with high fat/high calorie meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4.	Part1 Cohort1: PF-07202954 10mg/Placebo/PF-07202954 600mg/PF-07202954 100mg High Fat Meal Participants were administered a single oral dose of PF-07202954 10 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of placebo with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 600 mg with a std meal and PF-07202954 100 mg with high fat/high calorie meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4.	Part1 Cohort1: PF-07202954 10mg/PF-07202954 100mg Std Meal/Placebo/PF-07202954 100mg High Fat Meal Participants were administered a single oral dose of PF-07202954 10 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 100 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of placebo with a std meal and PF-07202954 100 mg with high fat/high calorie meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4.	Part1 Cohort1: PF-07202954 10mg/PF-07202954 100mg Std Meal/PF-07202954 600mg/Placebo Participants were administered a single oral dose of PF-07202954 10 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 100 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 600 mg and placebo with std meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4.	Part1 Cohort2: Placebo/PF-07202954 300mg/PF-07202954 100mg Std Meal/PF-07202954 100mg Fasted Participants were administered a single oral dose of placebo with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 300 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 100 mg with a std meal and PF-07202954 100 mg under fasting condition on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4.	Part1 Cohort2: PF-07202954 30mg/Placebo/PF-07202954 100mg Std Meal/PF-07202954 100mg Fasted Participants were administered a single oral dose of PF-07202954 30 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of placebo with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 100 mg with a std meal and PF-07202954 100 mg under fasting condition on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4.	Part1 Cohort2: PF-07202954 30mg/PF-07202954 300mg/Placebo/PF-07202954 100mg Fasted Participants were administered a single oral dose of PF-07202954 30 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 300 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of placebo with a std meal and PF-07202954 100 mg under fasting condition on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4.	Part1 Cohort2: PF-07202954 30mg/PF-07202954 300mg/PF-07202954 100mg Std Meal/Placebo Participants were administered a single oral dose of PF-07202954 30 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 300 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 100 mg and placebo with a std meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4.
Part 1 Period 1 STARTED	2	1	2	1	2	1	1	2
Part 1 Period 1 COMPLETED	2	1	2	1	2	1	1	2
Part 1 Period 1 NOT COMPLETED	0	0	0	0	0	0	0	0
Part 1 Period 2 STARTED	2	1	2	1	2	1	1	2
Part 1 Period 2 COMPLETED	2	1	2	1	2	1	1	2
Part 1 Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0
Part 1 Period 3 STARTED	2	1	2	1	2	1	1	1
Part 1 Period 3 COMPLETED	2	1	2	1	2	1	1	1
Part 1 Period 3 NOT COMPLETED	0	0	0	0	0	0	0	0
Part 1 Period 4 STARTED	2	1	2	1	2	0	0	1
Part 1 Period 4 COMPLETED	2	1	2	1	2	0	0	1
Part 1 Period 4 NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study in Healthy Adults Evaluating PF-07202954

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

Population: Safety population included all participants who were randomly assigned to study treatment and who took at least 1 dose of study treatment. Treatment groups with same dose and administration were combined as planned.

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were AEs that occurred following the start of study treatment (either PF-07202954 or placebo) up to approximately 28 days after the last dose.

Outcome measures

Outcome measures
Measure	Cohort 1 and 2: Placebo: Part 1 n=11 Participants Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=9 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 n=2 Participants Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1	3 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

Population: Safety population included all participants who were randomly assigned to study treatment and who took at least 1 dose of study treatment. Treatment groups with same dose and administration were combined as planned.

Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (less than \[\<\] 0.8\* lower limit normal \[LLN\]); monocytes/leukocytes (greater than \[\>\] 1.2\* upper limit normal \[ULN\]); clinical chemistry: low density lipoprotein (LDL) (\>1.2\*ULN), creatine kinase (\>2.0\*ULN); and urinalysis: specific gravity (\<1.003); ketones, urine protein, urine hemoglobin, nitrite (greater than equal to \[\>=1\]), urine erythrocytes (\>= 20), red blood cells (RBC) casts (\>1), bacteria (\>20). Number of participants with any laboratory abnormality meeting pre-defined criteria was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1 and 2: Placebo: Part 1 n=11 Participants Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=9 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 n=2 Participants Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 1	0 Participants	2 Participants	3 Participants	6 Participants	5 Participants	3 Participants	4 Participants	2 Participants

PRIMARY outcome

Timeframe: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

Population: Safety population included all participants who were randomly assigned to study treatment and who took at least 1 dose of study treatment. Treatment groups with same dose and administration were combined as planned.

Vital signs were categorized according to the following criteria for potential clinical concern: diastolic blood pressure (DBP): \<50 millimeter of mercury (mmHg), increase from baseline \>= 20mmHg; systolic blood pressure (SBP): \<90 mmHg, increase from baseline \>=30mmHg; pulse rate: \<40 beats per minute (bpm), \>120 bpm.

Outcome measures

Outcome measures
Measure	Cohort 1 and 2: Placebo: Part 1 n=11 Participants Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=9 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 n=2 Participants Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Number of Participants According to Categorization of Vital Signs Data: Part 1 DBP: Increase from baseline >=20mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Vital Signs Data: Part 1 SBP: <90 mmHg	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Vital Signs Data: Part 1 SBP: Increase from baseline >=30 mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Vital Signs Data: Part 1 Pulse rate: <40 bpm	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Vital Signs Data: Part 1 Pulse rate: >120 bpm	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Vital Signs Data: Part 1 DBP: <50 mmHg	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

Population: Safety population included all participants who were randomly assigned to study treatment and who took at least 1 dose of study treatment. Treatment groups with same dose and administration were combined as planned.

ECG parameters were categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) \>=300, percent change \>=25/50 percent (%); QRS duration, aggregate (msec) \>=140, percent change \>= 50%; QT interval corrected by Fridericia's formula (QTcF) interval aggregate (msec): \>450 to \<=480, \> 480 to \<=500, \>500, change from baseline: \>30 to \<=60 and change \>60.

Outcome measures

Outcome measures
Measure	Cohort 1 and 2: Placebo: Part 1 n=11 Participants Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=9 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 n=2 Participants Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 PR interval aggregate (msec): >=300	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 PR interval aggregate (msec): percent change >=25/50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 QRS duration, aggregate (msec): >=140	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 QRS duration, aggregate (msec): percent change >=50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 QTcF interval aggregate (msec): >450 to <=480	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 QTcF interval aggregate (msec): >480 to <=500	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 QTcF interval aggregate (msec): >=500	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 QTcF interval aggregate (msec): >30 to <=60	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 QTcF interval aggregate (msec): change >60	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to a maximum of 12 weeks

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to a maximum of 12 weeks

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (\<0.8\* LLN); monocytes/leukocytes (\>1.2\* ULN); clinical chemistry: LDL (\>1.2\*ULN), creatine kinase (\>2.0\*ULN); and urinalysis: specific gravity (\<1.003); ketones, urine protein, urine hemoglobin, nitrite (\>=1), urine erythrocytes (\>=20), RBC casts (\>1), bacteria (\>20).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to a maximum of 12 weeks

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

Vital signs were planned to be categorized according to the following criteria for potential clinical concern: diastolic blood pressure: \<50 mmHg, increase from baseline \>=20mmHg; systolic blood pressure: \<90 mmHg, increase from baseline \>=30mmHg; pulse rate: \<40 bpm, \>120 bpm.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to a maximum of 12 weeks

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

ECG parameters were planned to be categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) \>=300, percent change \>=25/50%; QRS duration, aggregate (msec) \>=140, percent change \>=50%; QTcF interval aggregate (msec): \>450 to \<=480, \>480 to \<=500, \>500, change from baseline: \>30 to \<=60 and change \>60.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Population: Data was not collected as no participants were enrolled in Part 3 of the study.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Population: Data was not collected as no participants were enrolled in Part 3 of the study.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Population: Data was not collected as no participants were enrolled in Part 3 of the study.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Population: Data was not collected as no participants were enrolled in Part 3 of the study.

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Population: Pharmacokinetic (PK) parameter population included all participants who received at least 1 dose of PF-07202954 and had at least 1 of the PK parameters of interest calculated in Part 1. PK data was not summarized for doses with less than 3 participants as pre-specified in statistical analysis plan; hence, individual values were reported for 'Cohort 2: PF-07202954 100 mg Fasted: Part 1' arm. Treatment groups with same dose and administration were combined as planned.

Outcome measures

Outcome measures
Measure	Cohort 1 and 2: Placebo: Part 1 n=4 Participants Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=9 Participants Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=2 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 1	23.92 Nanogram per milliliter Geometric Coefficient of Variation 20	55.64 Nanogram per milliliter Geometric Coefficient of Variation 28	226.6 Nanogram per milliliter Geometric Coefficient of Variation 26	774.2 Nanogram per milliliter Geometric Coefficient of Variation 27	2067 Nanogram per milliliter Geometric Coefficient of Variation 66	195.7 Nanogram per milliliter Geometric Coefficient of Variation 20	NA Nanogram per milliliter Geometric Coefficient of Variation NA Data for this arm was not summarized per plan. Individual values for participants were 326 and 290.	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Population: PK parameter population included all participants who received at least 1 dose of PF-07202954 and who had at least 1 of the PK parameters of interest calculated in Part 1. Treatment groups with same dose and administration were combined as planned.

Outcome measures

Outcome measures
Measure	Cohort 1 and 2: Placebo: Part 1 n=4 Participants Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=9 Participants Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=2 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Time for Cmax (Tmax) of PF-07202954: Part 1	1.500 Hours Interval 0.5 to 2.0	0.7500 Hours Interval 0.5 to 2.0	3.000 Hours Interval 0.5 to 4.0	1.000 Hours Interval 0.5 to 2.1	1.750 Hours Interval 0.5 to 3.0	3.000 Hours Interval 0.5 to 4.0	NA Hours It was pre-specified to summarize all PK outcome measures at the group level for 3 or more participants; hence data are not available for this arm.	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Population: PK parameter population included all participants who received at least 1 dose of PF-07202954 and who had at least 1 of the PK parameters of interest calculated in Part 1. PK data was not summarized for doses with less than 3 participants as pre-specified in the statistical analysis plan; hence, individual values were reported for 'Cohort 2: PF-07202954 100 mg Fasted: Part 1' arm. Treatment groups with same dose and administration were combined as planned.

AUClast was determined by linear/log trapezoidal method.

Outcome measures

Outcome measures
Measure	Cohort 1 and 2: Placebo: Part 1 n=4 Participants Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=9 Participants Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=2 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 1	179.9 Nanogram*hour per milliliter Geometric Coefficient of Variation 30	402.1 Nanogram*hour per milliliter Geometric Coefficient of Variation 14	1905 Nanogram*hour per milliliter Geometric Coefficient of Variation 27	5506 Nanogram*hour per milliliter Geometric Coefficient of Variation 13	13850 Nanogram*hour per milliliter Geometric Coefficient of Variation 28	1834 Nanogram*hour per milliliter Geometric Coefficient of Variation 28	NA Nanogram*hour per milliliter Geometric Coefficient of Variation NA Data for this arm was not summarized per plan. Individual values for participants were 2230 and 2160.	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Population: PK parameter population included all participants who received at least 1 dose of PF-07202954 and who had at least 1 of the PK parameters of interest calculated in Part 1. PK data was not summarized for doses with less than 3 participants as pre-specified in the statistical analysis plan; hence, individual values were reported for 'Cohort 2: PF-07202954 100 mg Fasted: Part 1' arm. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

AUCinf was determined as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate constant. Treatment groups with same dose and administration were combined as planned.

Outcome measures

Outcome measures
Measure	Cohort 1 and 2: Placebo: Part 1 n=4 Participants Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=9 Participants Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=2 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 1	185.6 Nanogram*hour per milliliter Geometric Coefficient of Variation 29	410.1 Nanogram*hour per milliliter Geometric Coefficient of Variation 14	1935 Nanogram*hour per milliliter Geometric Coefficient of Variation 28	5580 Nanogram*hour per milliliter Geometric Coefficient of Variation 13	13980 Nanogram*hour per milliliter Geometric Coefficient of Variation 28	1784 Nanogram*hour per milliliter Geometric Coefficient of Variation 30	NA Nanogram*hour per milliliter Geometric Coefficient of Variation NA Data for this arm was not summarized per plan. Individual values for participants were 2230 and 2180.	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Population: PK parameter population included all participants who received at least 1 dose of PF-07202954 and who had at least 1 of the PK parameters of interest calculated in Part 1. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Treatment groups with same dose and administration were combined as planned.

Outcome measures

Outcome measures
Measure	Cohort 1 and 2: Placebo: Part 1 n=4 Participants Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=9 Participants Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=5 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=4 Participants Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=2 Participants Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Terminal Half-life (t1/2) of PF-07202954: Part 1	5.740 Hours Standard Deviation 1.1641	5.615 Hours Standard Deviation 1.6562	11.43 Hours Standard Deviation 5.8788	10.55 Hours Standard Deviation 3.9217	14.81 Hours Standard Deviation 6.7702	15.85 Hours Standard Deviation 1.9209	NA Hours Standard Deviation NA It was pre-specified to summarize all PK outcome measures at the group level for 3 or more participants; hence data are not available for this arm.	—

SECONDARY outcome

Timeframe: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

Area under the concentration curve from time 0 to end of dosing interval (AUCtau).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

Aetau was defined as amount of unchanged drug recovered in urine during dosing interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

Aetau% was defined as percent of dose recovered in urine as unchanged drug over dosing interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

Population: Data was not collected as no participants were enrolled in Part 2 of the study.

Renal clearance was amount of unchanged drug excreted in urine over the dosing interval divided by AUCtau.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to maximum of 6 weeks

Population: Data was not collected as no participants were enrolled in Part 3 of the study.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to maximum of 6 weeks

Population: Data was not collected as no participants were enrolled in Part 3 of the study.

Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (\<0.8\* LLN); monocytes/leukocytes (\>1.2\* ULN); clinical chemistry: LDL (\>1.2\*ULN), creatine kinase (\>2.0\*ULN); and urinalysis: specific gravity (\<1.003); ketones, urine protein, urine hemoglobin, nitrite (\>=1), urine erythrocytes (\>=20), RBC casts (\>1), bacteria (\>20).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to maximum of 6 weeks

Population: Data was not collected as no participants were enrolled in Part 3 of the study.

Vital signs were planned to be categorized according to the following criteria for potential clinical concern: diastolic blood pressure: \<50 mmHg, increase from baseline \>=20mmHg; systolic blood pressure: \<90 mmHg, increase from baseline \>=30mmHg; pulse rate: \<40 bpm, \>120 bpm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to maximum of 6 weeks

Population: Data was not collected as no participants were enrolled in Part 3 of the study.

ECG parameters were planned to be categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) \>=300, percent change \>=25/50%; QRS duration, aggregate (msec) \>=140, percent change \>=50%; QTcF interval aggregate (msec): \>450 to \<=480, \>480 to \<=500, \>500, change from baseline: \>30 to \<=60 and change \>60.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1 and 2: Placebo: Part 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 1: PF-07202954 10 mg: Part 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2: PF-07202954 30 mg: Part 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2: PF-07202954 300 mg: Part 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 1: PF-07202954 600 mg: Part 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 2: PF-07202954 100 mg Fasted: Part 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 and 2: Placebo: Part 1 n=11 participants at risk Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 10 mg: Part 1 n=4 participants at risk Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 30 mg: Part 1 n=4 participants at risk Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period.	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n=9 participants at risk Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 300 mg: Part 1 n=5 participants at risk Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 600 mg: Part 1 n=4 participants at risk Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period.	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n=5 participants at risk Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period.	Cohort 2: PF-07202954 100 mg Fasted: Part 1 n=2 participants at risk Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period.
Eye disorders Conjunctival haemorrhage	9.1% 1/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	20.0% 1/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
Gastrointestinal disorders Nausea	0.00% 0/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	20.0% 1/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	20.0% 1/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
General disorders Application site irritation	9.1% 1/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	25.0% 1/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
Injury, poisoning and procedural complications Procedural pain	9.1% 1/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
Investigations Lymph node palpable	0.00% 0/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	11.1% 1/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
Nervous system disorders Paraesthesia	0.00% 0/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	25.0% 1/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
Nervous system disorders Somnolence	0.00% 0/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	11.1% 1/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	11.1% 1/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	20.0% 1/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
Reproductive system and breast disorders Menstruation irregular	9.1% 1/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
Respiratory, thoracic and mediastinal disorders Respiratory symptom	0.00% 0/11 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	11.1% 1/9 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/4 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/5 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.	0.00% 0/2 • From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1 Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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 the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Part 1 Cohort 1: All Participants n=6 Participants All participants who were randomized to either of the four treatment sequences in Cohort 1 and received placebo and escalating doses of PF-07202954 either with std meal or with high fat/high calorie meal in Periods 1, 2, 3 or 4 were included. All doses were administered once on Day 1 of each period via the oral route. The dosing in each period was separated by an interval of at least 10 days.	Part 1 Cohort 2: All Participants n=6 Participants All participants who were randomized to either of the four treatment sequences in Cohort 2 and received placebo and escalating doses of PF-07202954 with either std meal or under fasting condition in Period 1, 2, 3 or 4 were included. All doses were administered once on Day 1 of each period via the oral route. The dosing in each period was separated by an interval of at least 10 days.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants