Actively Recruiting
A Phase 1, Open-Label, Randomized, Single-Dose, 4-Period Crossover Study to Compare Bioavailability and Food Effects of New and Original Ibuzatrelvir Tablets in Healthy Adults
Led by Pfizer · Updated on 2026-04-27
18
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, open-label, randomized crossover study to evaluate how the study drug ibuzatrelvir is absorbed into the bloodstream of healthy adults. The trial compares the amount of ibuzatrelvir in blood after taking different tablet formulations, including the original and new tablets, both with and without food. The study also assesses the safety and tolerability of the medication. Participants will take a single dose of ibuzatrelvir in four different ways across four dosing periods: the original tablet fasted, the new tablet fasted, the new tablet dispersed in water fasted, and the new tablet fed. Each dosing period lasts 2 to 3 days, and participants will stay in the clinical research unit for 9 nights and 10 days to complete all dosing and procedures. The study uses a crossover design where each participant receives all treatment types in varied sequences. During the study, participants will have blood and urine samples collected for safety and to measure drug levels, with up to 40 blood draws for pharmacokinetics. They will also undergo up to 8 ECGs to monitor heart activity. Participants must fast overnight before most doses. After the inpatient stay, a follow-up phone call will occur 28 to 35 days after the last dose. Total participation lasts about 10 to 11 weeks.
CONDITIONS
Brief 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
- Body mass index (BMI) between 16 and 32 kg/m2 and body weight over 45 kg
- Able to give informed consent and willing to comply with study visits, treatment plans, lab tests, lifestyle requirements, and procedures
You will not qualify if you...
- History or evidence of significant blood, kidney, endocrine, lung, digestive, heart, liver, psychiatric, neurological, or allergic diseases (except untreated, asymptomatic seasonal allergies)
- Conditions affecting drug absorption such as gastrectomy or cholecystectomy
- History of HIV, hepatitis B or C infection, or positive tests for HIV, hepatitis B surface antigen, or hepatitis C antibody
- Any medical or psychiatric condition, including recent suicidal thoughts or behavior, that increases study risk or makes participation inappropriate
- Use of prescription, nonprescription drugs, or supplements within 14 days or 5 half-lives before dosing; moderate or strong CYP3A inducers prohibited
- Prior use of investigational drugs or vaccines within 30 days or 5 half-lives before dosing
- Participation in other investigational product studies during this trial
- Positive urine drug test (one repeat allowed)
- High blood pressure above specified limits based on age
- Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m²
- Abnormal ECG findings affecting safety or results, including specific heart rhythm or conduction issues
- Elevated liver enzymes or bilirubin above 1.5 times the upper limit of normal
- History of alcohol abuse, repeated binge drinking, or illicit drug use within 6 months
- Investigator site staff, their families, sponsor staff involved in the study, and their families
- Tobacco or nicotine use exceeding 5 cigarettes or 2 chews per day
- Known sensitivity to ibuzatrelvir or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 days
Participants receive single doses of ibuzatrelvir tablets in four different periods under various conditions to compare drug absorption, while staying in the clinical research unit.
Continuous stay in the clinical research unit for 9 nights and 10 days
Duration - Approximately 1 week
Participants have a follow-up phone call to assess safety and tolerability after the last dose.
1 phone call
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
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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