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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Incyte Corporation
Study ID
NCT06909162
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • INCB123667 — DRUG
    single dose administered orally
  • itraconazole — DRUG
    Oral: Tablet
  • carbamazepine — DRUG
    Oral; Tablet

Study Details

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.

Key Dates

Start date
May 5, 2025
Status verified
May 2026
Primary completion
May 17, 2026
Completion
May 17, 2026

Study Design

Enrollment
51 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Treatment A - INCB123667 Fasted
    INCB123667 will be administered at the protocol defined dose.
  • Experimental: Cohort 1: Treatment B - INCB123667 Fed
    INCB123667 will be administered at the protocol defined dose.
  • Experimental: Cohort 2: INCB123667 and itraconazole
    INCB123667 and itraconazole will be administered at protocol defined doses.
  • Experimental: Cohort 3: INCB123667 and carbamazepine
    INCB123667 and carbamazepine will be administered at protocol defined doses.

Primary Outcome Measure

Pharmacokinetics Parameter (PK): Cmax of INCB123667 [ Time Frame: Up to Day 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, IncLincolnNebraska68502-

Find similar trials in Lincoln, NE

By research site
Celerion, Inc· Lincoln, NE

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