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Recruiting Phase 1 NCT06909162

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

Trial Parameters

Condition Healthy Participants
Sponsor Incyte Corporation
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 51
Sex ALL
Min Age 19 Years
Max Age 55 Years
Start Date 2025-05-05
Completion 2026-04-18
Interventions
INCB123667itraconazolecarbamazepine

Brief 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 Criteria

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. * Fema

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