A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different T… (NCT07552779) | Clinical Trial Compass
RecruitingPhase 1
A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir
Belgium18 participantsStarted 2026-04-13
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
. BMI of 16-32 kg/m2; and a total body weight \>45 kg.
. Participants who are capable of giving signed informed consent and willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures.
Exclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast) in the fasted state
Timeframe: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
2
Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast) in the fasted state
Timeframe: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
3
Plasma ibuzatrelvir Cmax in the fasted state
Timeframe: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
4
Plasma ibuzatrelvir Cmax in the fasted state
Timeframe: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years 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 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention with the exception of moderate or strong CYP3A inducers which are prohibited within 14 days plus 5 half-lives 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.
. 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.
. An eGFR \<60 mL/min/1.73 m² as determined by the CKD-EPI equation using Screat.