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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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

Key facts

Study ID: NCT07018635
Run by: Incyte Corporation
People needed: 63
Starts: 2025-07-16
Expected to finish: 2025-09-29
Last updated by the study team: 2025-11-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

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 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.

Where it is running

Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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