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: No
• Genders Eligible for Study: All

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
Maximum Observed Plasma Concentration (Cmax) of PF-07321332		Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332		Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) and Day 10 (1, 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 time point on 12 hours of PF-07321332		Day 1 (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 of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Average concentration (Cav) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Accumulation ratio for AUCtau following multiple dosing (Rac) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Rac,Cmax of PF-07321332	Accumulation ratio for Cmax	Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Peak-to-trough ratio (PTR) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Apparent clearance (CL/F) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Apparent volume of distribution (Vz/F) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Terminal elimination half life (T½) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Pre-dose concentration (Ctrough) of PF-07321332		Day 5 (pre-dose), Day 8 (pre-dose) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants reporting an adverse event		From baseline up to Day 45
Number of participants reporting abnormal vital signs		From baseline up to Day 45
Number of participants reporting abnormal ECGs		From baseline up to Day 45
Number of participants reporting abnormal clinical safety laboratory tests		From baseline up to Day 45
Cmax of ritonavir		Day 1 (0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Tmax of ritonavir		Day 1 (0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
AUC12 of ritonavir		Day 1 (0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
AUCtau of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
AUClast of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Cav of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Rac of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Rac,Cmax of ritonavir	Accumulation ratio for Cmax	Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
PTR of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
CL/F of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Vz/F of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
T1/2 of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Ctrough of ritonavir		Day 5 (pre-dose), Day 8 (pre-dose) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)

Collaborators and Investigators

• Sponsor: 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): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

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