A Study to Learn How the Study Medicine Called Ibuzatrelvir is Taken up Into the Blood in Healthy Chinese Adults

NCT ID: NCT07235137

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-16
• Study Completion Date: 2025-11-21

Brief Summary

A study to learn how the study medicine called Ibuzatrelvir is taken up into the blood in healthy Chinese adults.

Detailed Description

To evaluate the PK profile of ibuzatrelvir after administration in Chinese healthy participants

Conditions

Healthy Participant

Keywords

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), coronavirus disease 2019 (COVID-19)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ibuzatrelvir

Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers

Group Type: EXPERIMENTAL

Ibuzatrelvir

Intervention Type: DRUG

Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers

Interventions

Ibuzatrelvir

Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers

Intervention Type: DRUG

Other Intervention Names

PF-07817883

Eligibility Criteria

Inclusion Criteria

• Male and female participants aged from 18 years old or older at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
• BMI of 16-32 kg/m2 (both inclusive); and a total body weight >45 kg (99 lbs.).
• Chinese male and female participants are defined as individuals currently residing in mainland China who were born in China and have both parents of Chinese descent.

Exclusion:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
• History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
• Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
• A positive urine drug test. A single repeat for positive drug screen may be allowed.
• Pregnant or breastfeeding women.
• Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times, and the average of the 3 BP values should be used to determine the participant's eligibility.
• Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (e.g., QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST segment and/or T wave changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmia or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs with abnormal findings should be overread by a physician experienced in reading ECGs before excluding a participant.
• Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: ALT, AST, Bilirubin ≥1.5× ULN

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C5091002

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

Other Identifiers

C5091002

Identifier Type: -

Identifier Source: org_study_id