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

NCT06909162 | Recruiting Phase 1 FDA Drug

• 1 other identifier: INCB123667-102
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

INCB123667

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics Parameter (PK): Cmax of INCB123667

  Defined as the maximum observed plasma or serum concentration.

  Up to Day 16

• Pharmacokinetics Parameter: Tmax of INCB123667

  Defined as the time to maximum concentration.

  Up to Day 16

• Pharmacokinetics Parameter: AUCt of INCB123667

  Defined as the area under the steady-state plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

  Up to Day 16

• Pharmacokinetics Parameter: AUC∞ of INCB123667

  Defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity.

  Up to Day 16

Secondary Outcomes (5)

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Up to Day 45

• Pharmacokinetics Parameter: tmax of INCB123667

  Up to Day 16

• Pharmacokinetics Parameter: t½ of INCB123667

  Up to Day 16

• Pharmacokinetics Parameter: CL/F of INCB123667

  Up to Day 16

• Pharmacokinetics Parameter: Vz/F of INCB123667

  Up to Day 16

Study Arms (4)

Cohort 1: Treatment A - INCB123667 Fasted

EXPERIMENTAL

INCB123667 will be administered at the protocol defined dose.

Drug: INCB123667

Cohort 1: Treatment B - INCB123667 Fed

EXPERIMENTAL

INCB123667 will be administered at the protocol defined dose.

Drug: INCB123667

Cohort 2: INCB123667 and itraconazole

EXPERIMENTAL

INCB123667 and itraconazole will be administered at protocol defined doses.

Drug: INCB123667; Drug: itraconazole

Cohort 3: INCB123667 and carbamazepine

EXPERIMENTAL

INCB123667 and carbamazepine will be administered at protocol defined doses.

Drug: INCB123667; Drug: carbamazepine

Interventions

INCB123667 DRUG

single dose administered orally

Cohort 1: Treatment A - INCB123667 Fasted; Cohort 1: Treatment B - INCB123667 Fed; Cohort 2: INCB123667 and itraconazole; Cohort 3: INCB123667 and carbamazepine

itraconazole DRUG

Oral: Tablet

Cohort 2: INCB123667 and itraconazole

carbamazepine DRUG

Oral; Tablet

Cohort 3: INCB123667 and carbamazepine

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 confirmed.
• Female participants not considered to be of childbearing potential as defined in the protocol are eligible.

You may not qualify if:

• History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
• History of an autoimmune disease diagnosis (i.e., myasthenia gravis).
• History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure \> 140 mm Hg or diastolic blood pressure \> 90 mm Hg at screening, confirmed by repeat testing).
• Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
• History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
• Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy; excluding appendectomy and hernia repair) that could affect the absorption of study drug.
• Confirmed resting pulse rate (up to 2 consecutive measurements) \< 40 bpm or \> 100 bpm at screening.
• Hepatic transaminases (ALT and AST), ALP, or total bilirubin \> 1.25 × the laboratory-defined ULN at screening or at each check-in, confirmed by repeat testing (except participants with Gilbert's disease, for whom total bilirubin must be ≤ 2.0 × ULN).
• Estimated glomerular filtration rate \< 90 mL/min / 1.73 m2 based on the site's standard formula at screening (eGFR \[mL/min\] = eGFR \[mL/min / 1.73m2\] × \[body surface area / 1.73\]).
• NOTE: Assessment of eGFR may be repeated once if outside of the reference range.
• Any major surgery within 4 weeks of screening.
• Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for donation of plasma only).
• Blood transfusion within 4 months of check-in (Day -1).
• Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent treated tuberculosis).
• Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion, Inc

Lincoln, Nebraska, 68502, United States

RECRUITING

Related Links

• A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics of INCB123667 When Administered Orally to Healthy Adult Participants

MeSH Terms

Interventions

Itraconazole; Carbamazepine

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): May 17, 2026
• Study Completion (Estimated): May 17, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)