Actively Recruiting
A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir
Led by Pfizer · Updated on 2026-04-27
18
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Healthy adults will be enrolled into this open-label, Phase 1 research study. Participants will spend about 9 nights and 10 days in the clinical research unit (CRU) and the total time in the study will be about 11 weeks. The goal of this clinical trial is to compare how much of the study drug ibuzatrelvir is in participants' blood after taking one of the two different types of tablets containing the same amount of ibuzatrelvir without food. The study will also measure how much ibuzatrelvir is in participants' blood after taking one type of the tablets dispersed in water and when one type of the tablets is taken with food. This study drug is taken by mouth.
CONDITIONS
Official Title
A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at screening and overtly healthy based on medical evaluation including history, physical exam, labs, and ECGs
- Body mass index (BMI) between 16 and 32 kg/m2 and total body weight over 45 kg
- Able to give signed informed consent and willing to comply with all study visits, treatments, tests, and procedures
You will not qualify if you...
- History or evidence of significant blood, kidney, hormone, lung, digestive, heart, liver, psychiatric, neurological, or allergic diseases (except untreated, asymptomatic seasonal allergies)
- Conditions affecting drug absorption such as gastrectomy or cholecystectomy
- History or positive test for HIV, hepatitis B, or hepatitis C (vaccination for hepatitis B allowed)
- Any medical or psychiatric condition including recent suicidal thoughts or behavior, lab abnormalities, or other risks judged by investigator
- Use of prescription or nonprescription drugs, dietary or herbal supplements within 14 days or 5 half-lives prior to dosing (except moderate or strong CYP3A inducers prohibited within 14 days plus 5 half-lives)
- Previous investigational drug or vaccine within 30 days or 5 half-lives before dosing
- Participation in other investigational product studies during this study
- Positive drug urine test (allowing one repeat test)
- High blood pressure above specified limits based on age after rest
- Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2
- Abnormal ECG findings affecting safety or results
- Liver enzyme or bilirubin levels above 1.5 times upper limit of normal
- History of alcohol abuse, repeated binge drinking, or illicit drug use within 6 months
- Investigator site staff or close family members involved in the study
- Use of tobacco or nicotine products exceeding 5 cigarettes or 2 chews daily
- History of sensitivity to ibuzatrelvir or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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