Clinical trial NCT07018635: A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
Official title: An Open-Label Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: INCB161734
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is conducted to assess the effect of itraconazole, rifampin, and acid-reducing agents on INCB161734 pharmacokinetics when administered orally in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Ability to comprehend and willingness to sign a written ICF for the study.
* Age 18 to 55 years, inclusive, at the time of signing the ICF.
* Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
* Willingness to adhere to study-related prohibitions, restrictions, and procedures.
* Ability to swallow and retain PO medication.
* Willingness to avoid pregnancy or fathering children based on the criteria defined in the prootcol.

Exclusion Criteria:

* History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
* History of rheumatologic/autoimmune disorders and immune deficiency/immunologic defects.
* History of major bleeding or thrombosis, including myocardial infarction/stroke and pulmonary embolism/deep vein thrombosis.
* Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
* Resting pulse \< 40 bpm or \> 100 bpm, confirmed by repeat testing at screening.
* Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
* Any major surgery within 12 weeks of screening.
* Positive test for hepatitis B virus, hepatitis C virus, or HIV. Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator.
* Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
* Use of tobacco- or nicotine-containing products within 1 month of screening.
* Women who are pregnant or breastfeeding.
* eGFR \< 90 mL/min/1.73 m2 based on the CKD-EPI equation.
* Any history of hypersensitivity or intolerance to itraconazole, rifampin, esomeprazole or any other PPI, or famotidine or any other H2 antagonist.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Primary outcomes:
measure: Pharmacokinetics Parameter (PK): Cmax of INCB161734
timeFrame: Up to 2 months
measure: Pharmacokinetics Parameter: AUC(0-t) of INCB161734
timeFrame: Up to 2 months
measure: Pharmacokinetics Parameter: AUC 0-∞ of INCB161734
timeFrame: Up to 2 months
Secondary outcomes:
measure: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 2 months
measure: Pharmacokinetics Parameter: Tmax of INCB161734
timeFrame: Up to 2 months
measure: Pharmacokinetics Parameter: t1/2 of INCB161734
timeFrame: Up to 2 months
measure: Pharmacokinetics Parameter: CL/V of INCB161734
timeFrame: Up to 2 months
measure: Pharmacokinetics Parameter: Vz/F of INCB161734
timeFrame: Up to 2 months
measure: Pharmacokinetics Parameter: AUC%extrap of INCB161734
timeFrame: Up to 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: