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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: PF-07321332/ritonavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), coronavirus disease 2019 (COVID-19)