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A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.

A Phase 1, Single Center, Open-label Study of PF-07321332 Administrated as Multiple Oral Doses in Healthy Chinese Participants.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05339334
Enrollment
14
Registered
2022-04-21
Start date
2022-03-10
Completion date
2022-04-21
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), coronavirus disease 2019 (COVID-19)

Brief summary

The purpose of this Phase 1 clinical trial is to help us understand how the drug is changed and eliminated from your body after you take it, the safety, and the the extent to which dise effects can be tolerated of PF-07321332 when PF-07321332 and ritonavir are given to healthy adult Chinese participants.

Interventions

PF-07321332/ritonavir will be given by mouth two times a day for 10 days

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy Chinese participants * No clinical relevant abnormalities * Body mass index (BMI):17.5-28

Exclusion criteria

* Any clinical significant illness * History of alcohol abuse * Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior the first study dose * Abnormal clinical lab tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, estimated glomerular filtration rate (eGFR) * Abnormal vital signs, such 12-electrocardiogram (ECG), blood pressure and pulse rate * Blood donation within 60 days * History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb) * Other medical or psychiatric may inappropriate for the study

Design outcomes

Primary

MeasureTime frameDescription
PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Cmax is maximum plasma concentration .
PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Cmax is maximum plasma concentration
PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Tmax is the time for maximum plasma concentration
PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Tmax is the time for maximum plasma concentration
PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Area under the plasma concentration-time profile from time Zero to time point on 12 hours
PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.
PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)This was determined by AUCtau/tau.
PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1.
PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1.
PF-07321332 Peak-to-trough Ratio (PTR) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)This was determined by Day 10 Cmax/Day 10 Ctrough.
PF-07321332 Apparent Clearance (CL/F) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Apparent oral clearance. This was determined by Dose/AUCtau.
PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Apparent oral volume of distribution.
PF-07321332 Terminal Elimination Half-life (t½) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)
PF-07321332 Trough Concentration (Ctrough) on Day 5Day 5 (pre-dose)Concentration at pre-dose on Day 5. Observed directly from data.
PF-07321332 Trough Concentration (Ctrough) on Day 8Day 8 (pre-dose)Concentration at pre-dose on Day 8. Observed directly from data.
PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)Day 10 (pre-dose)Concentration at pre-dose on Day 10. Observed directly from data.
PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)Day 10 (12 hours after last dose)Concentration at 12 hour time on Day 10. Observed directly from data.

Secondary

MeasureTime frameDescription
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)From baseline up to Day 42An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs.
Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)Day 10 (12 hours after last dose)Concentration at 12 hour on Day 10. Observed directly from data.
Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization CriteriaDay 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (\<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease \>= 30 mmHg, max. increase \>=30 mmHg; diastolic BP min. \<50mmHg; diastolic BP change from baseline max. decrease \>=20, max. increase \>=20; seated pulse rate min. \<40 beats per minute (bpm) and max. \>120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.
Number of Participants With Laboratory AbnormalitiesDay-1, Day 2, Day 5, Day 8, Day 10, Day 12.Safety laboratory assessments included hematology, urinalysis, and clinical chemistry.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization CriteriaDay 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds\[msec\]) \>450 and ≤480, or \>480 and ≤500, or \>500; Increase from baseline in QTcF (msec) \>30 and ≤60, or\>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline \>200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.
Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Cmax is maximum plasma concentration
Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Cmax is maximum plasma concentration
Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Tmax is the time for maximum plasma concentration
Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Tmax is the time for maximum plasma concentration
Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1.
Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.
Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)
Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)This was determined by AUCtau/tau.
Ritonavir Apparent Clearance (CL/F) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Apparent oral clearance. This was determined by Dose/AUCtau.
Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Apparent oral volume of distribution. This was determined by Dose/(AUCtau\*kel)
Ritonavir Terminal Elimination Half-life (t½) on Day 10Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Ritonavir Trough Concentration (Ctrough) on Day 5Day 5 (pre-dose)Concentration at pre-dose on Day 5. Observed directly from data.
Ritonavir Trough Concentration (Ctrough) on Day 8Day 8 (pre-dose)Concentration at pre-dose on Day 8. Observed directly from data.
Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)Day 10 (pre-dose)Concentration at pre-dose on Day 10. Observed directly from data.

Countries

China

Participant flow

Pre-assignment details

The study consisted of 1 treatment group: multiple oral doses of PF-07321332300 mg/ritonavir 100 mg. A total of 14 healthy participants were enrolled and treated.

Participants by arm

ArmCount
PF-07321332 300 mg + Ritonavir 100 mg
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
14
Total14

Baseline characteristics

CharacteristicPF-07321332 300 mg + Ritonavir 100 mg
Age, Continuous33.1 years
STANDARD_DEVIATION 6.78
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
14 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 14
other
Total, other adverse events
6 / 14
serious
Total, serious adverse events
0 / 14

Outcome results

Primary

PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10

Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1.

Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 101.627 ratioGeometric Coefficient of Variation 21
Primary

PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10

Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1.

Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 101.461 ratioGeometric Coefficient of Variation 22
Primary

PF-07321332 Apparent Clearance (CL/F) on Day 10

Apparent oral clearance. This was determined by Dose/AUCtau.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Apparent Clearance (CL/F) on Day 109.379 Liter/hour (L/h)Geometric Coefficient of Variation 21
Primary

PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10

Apparent oral volume of distribution.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Apparent Volume of Distribution (Vz/F) on Day 1091.01 Liters (L)Geometric Coefficient of Variation 29
Primary

PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10

Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 1041460 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 24
Primary

PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1

Area under the plasma concentration-time profile from time Zero to time point on 12 hours

Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 119660 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 26
Primary

PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10

Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 1032010 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 21
Primary

PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10

This was determined by AUCtau/tau.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 102668 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 21
Primary

PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1

Cmax is maximum plasma concentration .

Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 13082 nanograms per milliliter (ng/mL)Geometric Coefficient of Variation 29
Primary

PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10

Cmax is maximum plasma concentration

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 104500 nanograms per milliliter (ng/mL)Geometric Coefficient of Variation 14
Primary

PF-07321332 Peak-to-trough Ratio (PTR) on Day 10

This was determined by Day 10 Cmax/Day 10 Ctrough.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Peak-to-trough Ratio (PTR) on Day 104.517 ratioGeometric Coefficient of Variation 32
Primary

PF-07321332 Terminal Elimination Half-life (t½) on Day 10

Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Terminal Elimination Half-life (t½) on Day 106.842 Hours (hr)Standard Deviation 1.2336
Primary

PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1

Tmax is the time for maximum plasma concentration

Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (MEDIAN)
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 11.76 hours (hr)
Primary

PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10

Tmax is the time for maximum plasma concentration

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (MEDIAN)
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 102.00 hours (hr)
Primary

PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)

Concentration at 12 hour time on Day 10. Observed directly from data.

Time frame: Day 10 (12 hours after last dose)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)997.4 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 40
Primary

PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)

Concentration at pre-dose on Day 10. Observed directly from data.

Time frame: Day 10 (pre-dose)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)1333 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 32
Primary

PF-07321332 Trough Concentration (Ctrough) on Day 5

Concentration at pre-dose on Day 5. Observed directly from data.

Time frame: Day 5 (pre-dose)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Trough Concentration (Ctrough) on Day 51389 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 26
Primary

PF-07321332 Trough Concentration (Ctrough) on Day 8

Concentration at pre-dose on Day 8. Observed directly from data.

Time frame: Day 8 (pre-dose)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgPF-07321332 Trough Concentration (Ctrough) on Day 81481 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 27
Secondary

Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria

The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds\[msec\]) \>450 and ≤480, or \>480 and ≤500, or \>500; Increase from baseline in QTcF (msec) \>30 and ≤60, or\>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline \>200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.

Time frame: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)

Population: The analysis population included all participants who took at least 1 dose of study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-07321332 300 mg + Ritonavir 100 mgNumber of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria0 Participants
Secondary

Number of Participants With Laboratory Abnormalities

Safety laboratory assessments included hematology, urinalysis, and clinical chemistry.

Time frame: Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.

Population: The analysis population included all participants who took at least 1 dose of study intervention.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-07321332 300 mg + Ritonavir 100 mgNumber of Participants With Laboratory AbnormalitiesUrate (milligrams per decilitre[mg/dL]) > 1.2x upper limit of normal (ULN)2 Participants
PF-07321332 300 mg + Ritonavir 100 mgNumber of Participants With Laboratory AbnormalitiesFibrinogen (mg/dL) < 0.75x Baseline1 Participants
PF-07321332 300 mg + Ritonavir 100 mgNumber of Participants With Laboratory AbnormalitiesFibrinogen (mg/dL) > 1.25x Baseline2 Participants
PF-07321332 300 mg + Ritonavir 100 mgNumber of Participants With Laboratory AbnormalitiesUrine Hemoglobin ≥ 12 Participants
Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs.

Time frame: From baseline up to Day 42

Population: The analysis population included all participants who took at least 1 dose of study intervention.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-07321332 300 mg + Ritonavir 100 mgNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)TEAEs6 Participants
PF-07321332 300 mg + Ritonavir 100 mgNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)serious TEAEs0 Participants
Secondary

Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria

Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (\<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease \>= 30 mmHg, max. increase \>=30 mmHg; diastolic BP min. \<50mmHg; diastolic BP change from baseline max. decrease \>=20, max. increase \>=20; seated pulse rate min. \<40 beats per minute (bpm) and max. \>120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.

Time frame: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)

Population: The analysis population included all participants who took at least 1 dose of study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-07321332 300 mg + Ritonavir 100 mgNumber of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria0 Participants
Secondary

Ritonavir Apparent Clearance (CL/F) on Day 10

Apparent oral clearance. This was determined by Dose/AUCtau.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Apparent Clearance (CL/F) on Day 1016.25 Liter/hour (L/h)Geometric Coefficient of Variation 29
Secondary

Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10

Apparent oral volume of distribution. This was determined by Dose/(AUCtau\*kel)

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Apparent Volume of Distribution (Vz/F) on Day 10123.0 Liters (L)Geometric Coefficient of Variation 23
Secondary

Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10

Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 107118 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 33
Secondary

Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1

This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1.

Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 13136 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 49
Secondary

Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10

Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 106152 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 29
Secondary

Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10

This was determined by AUCtau/tau.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10512.9 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 29
Secondary

Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1

Cmax is maximum plasma concentration

Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Maximum Observed Plasma Concentration (Cmax) on Day 1545.8 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 50
Secondary

Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10

Cmax is maximum plasma concentration

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Maximum Observed Plasma Concentration (Cmax) on Day 101109 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 33
Secondary

Ritonavir Terminal Elimination Half-life (t½) on Day 10

Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Terminal Elimination Half-life (t½) on Day 105.471 Hours (hr)Standard Deviation 1.7871
Secondary

Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1

Tmax is the time for maximum plasma concentration

Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (MEDIAN)
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 12.00 hours (hr)
Secondary

Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10

Tmax is the time for maximum plasma concentration

Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (MEDIAN)
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 102.00 hours (hr)
Secondary

Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)

Concentration at 12 hour on Day 10. Observed directly from data.

Time frame: Day 10 (12 hours after last dose)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)134.9 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 44
Secondary

Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)

Concentration at pre-dose on Day 10. Observed directly from data.

Time frame: Day 10 (pre-dose)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)200.8 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 35
Secondary

Ritonavir Trough Concentration (Ctrough) on Day 5

Concentration at pre-dose on Day 5. Observed directly from data.

Time frame: Day 5 (pre-dose)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Trough Concentration (Ctrough) on Day 5233.3 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 38
Secondary

Ritonavir Trough Concentration (Ctrough) on Day 8

Concentration at pre-dose on Day 8. Observed directly from data.

Time frame: Day 8 (pre-dose)

Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-07321332 300 mg + Ritonavir 100 mgRitonavir Trough Concentration (Ctrough) on Day 8212.8 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 44

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026