A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Intera… (NCT06909162) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants
United States51 participantsStarted 2025-05-05
Plain-language summary
This study will be conducted to evaluate the effect of food on the single-dose pharmacokinetics and a drug-drug interaction evaluation of itraconazole and carbamazepine on INCB123667 when administered orally to healthy adult participants.
Who can participate
Age range
19 Years – 55 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:
* Ability to comprehend and willingness to sign a written ICF for the study.
* Age 19 (in compliance with Nebraska state law) to 55 years, inclusive, at the time of signing the ICF.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled with a BMI \> 30 to ≤ 32.0 kg/m2.
* No clinically significant findings on screening evaluations (clinical, laboratory results \[with the exception of lipids\], and ECGs).
* Ability to swallow and retain oral tablets.
* Willingness to avoid pregnancy or fathering children based on the criteria below:
* Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 180 days after the last dose of study drug and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
* Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy (Cohort 1) and negative serum pregnancy test (Cohorts 2 and 3) at check-in on Day -1 and must agree to take appropriate precautions to avoid pregnancy from screening through 180 days after the last dose of study drug and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirm…
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
Pharmacokinetics Parameter (PK): Cmax of INCB123667