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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: PF-07321332/ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05339334

C4671016

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

PF-07321332/ritonavir

Experimental group

Description:

PF-07321332/ritonavir will be given by mouth two times a day for 10 days to adult Chinese healthy volunteers

Treatment:

Drug: PF-07321332/ritonavir