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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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07235137
Enrollment
12
Registered
2025-11-19
Start date
2025-10-16
Completion date
2025-11-21
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participant

Keywords

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

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

Interventions

Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Maximum Observed Plasma Concentration (Cmax)up to Day 3
AUCinfup to Day 3
Terminal phase half-life (t½)up to Day 3

Secondary

MeasureTime frame
Adverse events and severe adverse eventsup to Day 3
Incidence of abnormal and clinically relevant changes in laboratory assessmentsUp to Day 3
Incidence of abnormal and clinically relevant changes in vital signsup to Day 3
Incidence of abnormal and clinically relevant changes in electrocardiogramUp to Day 3

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026