Trial Outcomes & Findings for Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function. (NCT NCT04909853)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Results posted on

2023-08-02

Participant Flow

Study had 2 parts, Part 1 and 2. Enrollment were separate for both the parts. A total of 35 participants (27 in Part 1 and 8 in Part 2) were enrolled in the study of which 34 participants received the study treatment.

Participants were grouped on the basis of severity of renal impairment. Severity was evaluated using estimated glomerular filtration rate (eGFR) in milliliter per minute (mL/min) based on chronic kidney disease-epidemiology collaboration (CKD-EPI) formula. Following were the classifications, a) Normal: eGFR greater than or equal to (\>=) 90 mL/min, b) Mild: eGFR 60 to less than (\<) 90 mL/min, c) Moderate: eGFR \>= 30 to \<60 mL/min and d) Severe: eGFR \<30 mL/min and not requiring dialysis.

Participant milestones

Participant milestones
Measure	Part 1: Normal Renal Function Participants with normal renal function received PF-07321332 100 milligram (mg) single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Part 1 STARTED	10	8	9	0
Part 1 Treated	10	8	8	0
Part 1 COMPLETED	10	8	8	0
Part 1 NOT COMPLETED	0	0	1	0
Part 2 STARTED	0	0	0	8
Part 2 COMPLETED	0	0	0	7
Part 2 NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Normal Renal Function Participants with normal renal function received PF-07321332 100 milligram (mg) single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Part 1 Assigned but not treated	0	0	1	0
Part 2 Adverse Event	0	0	0	1

Baseline Characteristics

Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Total n=34 Participants Total of all reporting groups
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	25 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	21 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Continuous	61.1 Years STANDARD_DEVIATION 3.03 • n=5 Participants	63.8 Years STANDARD_DEVIATION 9.07 • n=7 Participants	62.0 Years STANDARD_DEVIATION 8.57 • n=5 Participants	62.1 Years STANDARD_DEVIATION 9.46 • n=4 Participants	62.2 Years STANDARD_DEVIATION 7.45 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants

PRIMARY outcome

Timeframe: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Population: The pharmacokinetic (PK) parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Maximum Observed Plasma Concentration (Cmax) of PF-07321332	1600 Nanogram per milliliter Geometric Coefficient of Variation 31	2077 Nanogram per milliliter Geometric Coefficient of Variation 29	2210 Nanogram per milliliter Geometric Coefficient of Variation 17	2369 Nanogram per milliliter Geometric Coefficient of Variation 38

PRIMARY outcome

Timeframe: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.

AUCinf was calculated by AUClast + (Clast/kel). AUClast was the area under the plasma concentration-time profile from time 0 to the time of Clast. Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=6 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=7 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Area Under the Plasma Concentration-time Profile From Time Zero (0) to Extrapolated Infinite Time (AUCinf) of PF-07321332	14460 Nanogram*hour per milliliter Geometric Coefficient of Variation 20	17910 Nanogram*hour per milliliter Geometric Coefficient of Variation 30	27110 Nanogram*hour per milliliter Geometric Coefficient of Variation 27	44040 Nanogram*hour per milliliter Geometric Coefficient of Variation 33

PRIMARY outcome

Timeframe: Part 1 and Part 2: 0 to 48 hours post dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.

Total amount of unchanged drug excreted in the urine over 48 hours.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Amount of PF-07321332 Excreted Unchanged in Urine Over 48 Hours (Ae48)	31.20 Milligram Geometric Coefficient of Variation 45	42.65 Milligram Geometric Coefficient of Variation 23	30.83 Milligram Geometric Coefficient of Variation 56	18.46 Milligram Geometric Coefficient of Variation 50

PRIMARY outcome

Timeframe: Part 1 and Part 2: 0 to 48 hours post dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.

Renal clearance was calculated as total amount of unchanged drug excreted in the urine over 48 hours (Ae48) divided by area under the plasma concentration-time profile from time 0 to 48 hours post dose.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Renal Clearance (CLr) of PF-07321332	2.180 Liters per hour Geometric Coefficient of Variation 50	2.395 Liters per hour Geometric Coefficient of Variation 33	1.154 Liters per hour Geometric Coefficient of Variation 71	0.4398 Liters per hour Geometric Coefficient of Variation 73

SECONDARY outcome

Timeframe: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that, at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent was considered serious; other important medical events. TEAEs were events occurred following start of treatment or increased in severity up to maximum of 35 days after last dose. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness was judged by investigator.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs TEAEs	2 Participants	1 Participants	1 Participants	5 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs Treatment Emergent SAEs	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs Treatment-related AEs	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs Treatment-related SAEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

The hematology, clinical chemistry and urinalysis tests were included in the laboratory examination. The criteria for hematology evaluation included hemoglobin less than (\<) 0.8\*lower limit of normal (LLN), hematocrit \<0.8\*LLN, erythrocytes \<0.8\*LLN, erythrocyte mean corpuscular hemoglobin \<0.9\*LLN and lymphocytes \<0.8\*LLN. The criteria for clinical chemistry evaluation included neutrophils \<0.8\*LLN, eosinophils greater than (\>) 1.2\* upper limit of normal (ULN), monocytes \>1.2\*ULN, urea nitrogen \>1.3\*ULN, creatinine \>1.3\*ULN, urate \>1.2\*ULN, potassium \>1.1\*ULN and bicarbonate \<0.9\*LLN. The criteria for urinalysis evaluation included thyrotropin \>1.2\*ULN, glucose \>1.5\*ULN, fibrinogen \>1.25\*baseline, ketones greater than or equal to (\>=) 1, urine protein \>=1, nitrite \>=1 and leukocyte esterase \>=1.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Number of Participants With Clinical Laboratory Abnormalities	5 Participants	4 Participants	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Supine blood pressure, pulse rate, respiratory rate and oral temperature were evaluated in vital signs examination. Clinical significance was judged by investigator.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Number of Participants With Clinically Significant Vital Signs Abnormalities	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

A complete physical examination included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by investigator.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Number of Participants With Clinically Significant Findings in Physical Examination	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

A standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance was judged by investigator.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Plasma Concentration of PF-07321332 at 12 Hours Post Dose (C12)	341.9 Nanogram per milliliter Geometric Coefficient of Variation 35	438.0 Nanogram per milliliter Geometric Coefficient of Variation 30	785.6 Nanogram per milliliter Geometric Coefficient of Variation 33	1213 Nanogram per milliliter Geometric Coefficient of Variation 33

SECONDARY outcome

Timeframe: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Plasma Concentration of PF-07321332 at 24 Hours Post Dose (C24)	99.10 Nanogram per milliliter Geometric Coefficient of Variation 35	112.8 Nanogram per milliliter Geometric Coefficient of Variation 55	179.1 Nanogram per milliliter Geometric Coefficient of Variation 108	694.2 Nanogram per milliliter Geometric Coefficient of Variation 42

SECONDARY outcome

Timeframe: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.

Tmax was observed directly from data as time of first occurrence.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332	2.000 Hours Interval 1.0 to 4.0	2.000 Hours Interval 1.0 to 3.0	2.500 Hours Interval 1.0 to 6.0	3.000 Hours Interval 1.0 to 6.05

SECONDARY outcome

Timeframe: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.

Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration was determined by linear/log trapezoidal method.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Area Under the Plasma Concentration-time Profile From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332	14270 Nanogram*hour per milliliter Geometric Coefficient of Variation 20	17770 Nanogram*hour per milliliter Geometric Coefficient of Variation 30	26660 Nanogram*hour per milliliter Geometric Coefficient of Variation 21	39420 Nanogram*hour per milliliter Geometric Coefficient of Variation 28

SECONDARY outcome

Timeframe: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. CL/F was calculated by Dose/AUCinf.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=6 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=7 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Apparent Clearance (CL/F) of PF-07321332 From Plasma	6.913 Liters per hour Geometric Coefficient of Variation 20	5.581 Liters per hour Geometric Coefficient of Variation 30	3.689 Liters per hour Geometric Coefficient of Variation 27	2.270 Liters per hour Geometric Coefficient of Variation 33

SECONDARY outcome

Timeframe: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F was calculated by dose/(AUCinf\*kel). kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=6 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=7 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Apparent Volume of Distribution (Vz/F) of PF-07321332	74.95 Liters Geometric Coefficient of Variation 35	51.95 Liters Geometric Coefficient of Variation 32	50.34 Liters Geometric Coefficient of Variation 27	42.73 Liters Geometric Coefficient of Variation 26

SECONDARY outcome

Timeframe: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Population: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.

t1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Outcome measures

Outcome measures
Measure	Part 1: Normal Renal Function n=10 Participants Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 Participants Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=6 Participants Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=7 Participants Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Terminal Elimination Plasma Half-life (t1/2) of PF-07321332	7.725 Hours Standard Deviation 1.8234	6.606 Hours Standard Deviation 1.5344	9.948 Hours Standard Deviation 3.4171	13.37 Hours Standard Deviation 3.3225

Adverse Events

Part 1: Normal Renal Function

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: Mild Renal Impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: Moderate Renal Impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2: Severe Renal Impairment

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Normal Renal Function n=10 participants at risk Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 participants at risk Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 participants at risk Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 participants at risk Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Infections and infestations Pneumonia	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Renal and urinary disorders Acute kidney injury	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Other adverse events

Other adverse events
Measure	Part 1: Normal Renal Function n=10 participants at risk Participants with normal renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Mild Renal Impairment n=8 participants at risk Participants with mild renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 1: Moderate Renal Impairment n=8 participants at risk Participants with moderate renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 1 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 1 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.	Part 2: Severe Renal Impairment n=8 participants at risk Participants with severe renal function received PF-07321332 100 mg single oral dose on Day 1 of Part 2 of the study. Participants were administered with pharmacokinetic boosting agent ritonavir 100 mg orally on Day -1 at -12 hours, Day 1 at 0 hours and 12 hours, and Day 2 at 24 hours, relative to PF-07321332 dosing in Part 2 of the study. Participants were followed-up to maximum of 35 days after the last administration of ritonavir or from the time of early termination/discontinuation.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Cardiac disorders Bradycardia	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Gastrointestinal disorders Dry mouth	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	25.0% 2/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
General disorders Asthenia	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	25.0% 2/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Nervous system disorders Dysgeusia	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	25.0% 2/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Nervous system disorders Headache	20.0% 2/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Psychiatric disorders Agitation	10.0% 1/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Vascular disorders Hypotension	0.00% 0/10 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Additional Information

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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 study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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