COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is conducted 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

Quick Facts

Study Start:2025-07-16

Study Completion:2025-09-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT07018635

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Incyte Medical Monitor

STUDY_DIRECTOR

Incyte Corporation

Study Locations (Sites)

Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison

Madison, Wisconsin, 53704

United States

Collaborators and Investigators

Sponsor: Incyte Corporation

Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16

Study Completion Date2025-09-29

Study Record Updates

Study Start Date2025-07-16

Study Completion Date2025-09-29

Terms related to this study

Keywords Provided by Researchers

INCB161734

Additional Relevant MeSH Terms

Healthy Participants