A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants

Phase 1

Not yet recruiting

• Conditions: Healthy Participants
• Interventions: Drug: INCB161734; Drug: Esomeprazole; Drug: Famotidine; Drug: Rifampin; Drug: Itraconazole

• Registration Number: NCT07018635
• Lead Sponsor: Incyte Corporation

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-18
• Study Start: 2025-07-16
• Primary Completion: 2025-10-29
• Study Completion: 2025-10-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 3	Esomeprazole	INCB161734 and esomeprazole will be administered at protocol defined doses.
Cohort 4	INCB161734	INCB161734 and famotidine will be administered at protocol defined doses.
Cohort 4	Famotidine	INCB161734 and famotidine will be administered at protocol defined doses.
Cohort 2	Rifampin	INCB161734 and rifampin will be administered at protocol defined doses.
Cohort 1	INCB161734	INCB161734 and itraconazole will be administered at protocol defined doses.
Cohort 1	Itraconazole	INCB161734 and itraconazole will be administered at protocol defined doses.
Cohort 2	INCB161734	INCB161734 and rifampin will be administered at protocol defined doses.
Cohort 3	INCB161734	INCB161734 and esomeprazole will be administered at protocol defined doses.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics Parameter (PK): Cmax of INCB161734	Up to 2 months	Defined as maximum observed plasma or serum concentration of INCB161734.
Pharmacokinetics Parameter: AUC(0-t) of INCB161734	Up to 2 months	Defined as the area under the concentration-time curve up to the last measurable concentration of INCB161734.
Pharmacokinetics Parameter: AUC 0-∞ of INCB161734	Up to 2 months	Defined as the area under the concentration-time curve from 0 to infinity of INCB161734.

Secondary Outcome Measures

Name	Time	Method
Number of participants with Treatment-emergent Adverse Events (TEAEs)	Up to 2 months	Defined as adverse events reported for the first time or the worsening of a pre-existing event, occurring after first dose of study drug.
Pharmacokinetics Parameter: Tmax of INCB161734	Up to 2 months	Defined as the time to reach the maximum plasma concentration of INCB161734.
Pharmacokinetics Parameter: t1/2 of INCB161734	Up to 2 months	Defined as the apparent terminal phase disposition half-life of INCB161734.
Pharmacokinetics Parameter: CL/V of INCB161734	Up to 2 months	Defined as the apparent oral dose clearance of INCB161734.
Pharmacokinetics Parameter: Vz/F of INCB161734	Up to 2 months	Defined as the apparent oral dose volume of distribution of INCB161734.
Pharmacokinetics Parameter: AUC%extrap of INCB161734	Up to 2 months	Defined as percentage of AUC∞ (_obs, _pred) due to extrapolation from time of last measurable observed concentration to infinity of INCB161734.