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

Launched by INCYTE CORPORATION · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study how certain medications—itraconazole, rifampin, and acid-reducing agents—affect the way a new drug, INCB161734, is processed in the body when taken by healthy adults. Researchers want to understand how these medications interact with INCB161734, which can help determine the best way to use this drug in the future.

To be eligible for this study, participants need to be healthy adults aged 18 to 55 years, with a body mass index (BMI) between 18.0 and 32.0. They should be able to take oral medications and agree to follow the study rules, including avoiding pregnancy. However, individuals with certain health conditions, recent surgeries, or those who have tested positive for specific infections will not be able to participate. If you join the trial, you can expect close monitoring and guidance from the research team throughout the study.

Gender

ALL

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.