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

A Phase 1, Single Arm Study to Evaluate the Pharmacokinetics Following Single Dose of PF-07817883 (Ibuzatrelvir) in Healthy Chinese Adult Participants.

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

Study Overview

• Status: Completed
• Conditions: Healthy Participant
• Intervention / Treatment: Drug: Ibuzatrelvir

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• 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: Ibuzatrelvir; Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers	Drug: Ibuzatrelvir; Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers; Other Names: PF-07817883

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax)	up to Day 3
AUCinf	up to Day 3
Terminal phase half-life (t½)	up to Day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events and severe adverse events	up to Day 3
Incidence of abnormal and clinically relevant changes in vital signs	up to Day 3
Incidence of abnormal and clinically relevant changes in electrocardiogram	Up to Day 3
Incidence of abnormal and clinically relevant changes in laboratory assessments	Up to Day 3

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, 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): October 16, 2025
• Primary Completion (Actual): November 21, 2025
• Study Completion (Actual): November 21, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

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: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: C5091002

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes