Actively Recruiting
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
Led by Incyte Corporation · Updated on 2026-05-06
51
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign the study consent form.
- Age between 19 and 55 years at consent.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2; up to 25% may have BMI over 30.
- No significant clinical findings on screening exams including labs and ECGs.
- Ability to swallow and keep oral tablets.
- Willingness to avoid pregnancy or fathering children during the study and 180 days after.
- Female participants must have negative pregnancy tests at screening and just before dosing.
- Female participants not of childbearing potential are eligible.
You will not qualify if you...
- History of unstable or uncontrolled heart, lung, kidney, digestive, hormone, blood, psychiatric, or nervous system diseases within 6 months.
- History of autoimmune disease.
- History of cardiovascular, blood vessel, or clotting diseases or uncontrolled high blood pressure.
- Abnormal ECG findings considered significant by the investigator.
- History or presence of malabsorption syndromes affecting drug absorption.
- History of cancer within 5 years except certain skin or prostate cancers.
- Recent significant digestive disease or surgery affecting drug absorption.
- Resting pulse below 40 bpm or above 100 bpm.
- Abnormal blood counts or liver function tests outside set limits.
- Kidney function below required level.
- Major surgery within 4 weeks.
- Recent blood donation or clinical study participation.
- Blood transfusion within 4 months.
- Active infections needing treatment or history of tuberculosis.
- Positive tests for hepatitis B, C, or HIV (with some exceptions).
- Recent live vaccine use or planned vaccination during study.
- History of alcoholism or significant recent alcohol use.
- Positive tests for drugs or alcohol.
- Recent use of other investigational drugs or certain medications affecting drug metabolism.
- Consumption of certain citrus fruits before dosing.
- Known severe drug allergies or hypersensitivity to study drugs.
- Inability to undergo blood draws.
- Likely inability to follow study schedule.
- Recent tobacco or nicotine use.
- Recent use of prescription or certain nonprescription drugs except some allowed medications.
- Pregnant or breastfeeding women.
- Conditions interfering with study participation or safety.
- Excessive intense exercise recently.
- Certain abnormal vitamin or hormone levels.
- Positive genetic test for certain alleles in specific cohort due to increased risk of severe reactions.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Celerion, Inc
Lincoln, Nebraska, United States, 68502
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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