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

NCT ID: NCT05339334

Last Updated: 2024-10-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2022-04-21

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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PF-07321332/ritonavir

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

Group Type EXPERIMENTAL

PF-07321332/ritonavir

Intervention Type DRUG

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

Interventions

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PF-07321332/ritonavir

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4671016

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

Other Identifiers

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C4671016

Identifier Type: -

Identifier Source: org_study_id

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