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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: PF-07321332/ritonavir

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201107
      • Huashan Hospital,Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-07321332/ritonavir; PF-07321332/ritonavir will be given by mouth two times a day for 10 days to adult Chinese healthy volunteers	Drug: PF-07321332/ritonavir; PF-07321332/ritonavir will be given by mouth two times a day for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1	Cmax is maximum plasma concentration .	Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10	Cmax is maximum plasma concentration	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1	Tmax is the time for maximum plasma concentration	Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10	Tmax is the time for maximum plasma concentration	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
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	Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
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.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10	This was determined by AUCtau/tau.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
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.	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)
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.	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)
PF-07321332 Peak-to-trough Ratio (PTR) on Day 10	This was determined by Day 10 Cmax/Day 10 Ctrough.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Apparent Clearance (CL/F) on Day 10	Apparent oral clearance. This was determined by Dose/AUCtau.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10	Apparent oral volume of distribution.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
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.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
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)	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
PF-07321332 Trough Concentration (Ctrough) on Day 5	Concentration at pre-dose on Day 5. Observed directly from data.	Day 5 (pre-dose)
PF-07321332 Trough Concentration (Ctrough) on Day 8	Concentration at pre-dose on Day 8. Observed directly from data.	Day 8 (pre-dose)
PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)	Concentration at pre-dose on Day 10. Observed directly from data.	Day 10 (pre-dose)
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.	Day 10 (12 hours after last dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline up to Day 42
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.	Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)
Number of Participants With Laboratory Abnormalities	Safety laboratory assessments included hematology, urinalysis, and clinical chemistry.	Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.
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.	Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)
Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1	Cmax is maximum plasma concentration	Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10	Cmax is maximum plasma concentration	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1	Tmax is the time for maximum plasma concentration	Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10	Tmax is the time for maximum plasma concentration	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
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.	Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
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.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
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)	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10	This was determined by AUCtau/tau.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Ritonavir Apparent Clearance (CL/F) on Day 10	Apparent oral clearance. This was determined by Dose/AUCtau.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10	Apparent oral volume of distribution. This was determined by Dose/(AUCtau*kel)	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
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.	Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Ritonavir Trough Concentration (Ctrough) on Day 5	Concentration at pre-dose on Day 5. Observed directly from data.	Day 5 (pre-dose)
Ritonavir Trough Concentration (Ctrough) on Day 8	Concentration at pre-dose on Day 8. Observed directly from data.	Day 8 (pre-dose)
Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)	Concentration at pre-dose on Day 10. Observed directly from data.	Day 10 (pre-dose)
Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)	Concentration at 12 hour on Day 10. Observed directly from data.	Day 10 (12 hours after last dose)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): April 21, 2022
• Study Completion (Actual): April 21, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); coronavirus disease 2019 (COVID-19)
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Nirmatrelvir
• Other Study ID Numbers: C4671016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No