A Phase 1, Open-Label 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
Incyte Corporation
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.
Eligibility
- Age range
- 19–55 years
- Sex
- All
- Healthy volunteers
- Yes
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 child…
Interventions
- DrugINCB123667
single dose administered orally
- Drugitraconazole
Oral: Tablet
- Drugcarbamazepine
Oral; Tablet
Location
- Celerion, IncLincoln, Nebraska