A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
NCT ID: NCT07018635
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
63 participants
INTERVENTIONAL
2025-07-16
2025-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
INCB161734 and itraconazole will be administered at protocol defined doses.
INCB161734
Oral; Tablet
Itraconazole
Oral; Tablet
Cohort 2
INCB161734 and rifampin will be administered at protocol defined doses.
INCB161734
Oral; Tablet
Rifampin
Oral; Tablet
Cohort 3
INCB161734 and esomeprazole will be administered at protocol defined doses.
INCB161734
Oral; Tablet
Esomeprazole
Oral; Tablet
Cohort 4
INCB161734 and famotidine will be administered at protocol defined doses.
INCB161734
Oral; Tablet
Famotidine
Oral; Tablet
Interventions
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INCB161734
Oral; Tablet
Itraconazole
Oral; Tablet
Rifampin
Oral; Tablet
Esomeprazole
Oral; Tablet
Famotidine
Oral; Tablet
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison
Madison, Wisconsin, United States
Countries
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Related Links
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A study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
Other Identifiers
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INCB161734-103
Identifier Type: -
Identifier Source: org_study_id
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