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

Incyte

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Rifampin; Drug: Itraconazole; Drug: Famotidine; Drug: Esomeprazole; Drug: INCB161734

Study type: Interventional

Funder types: Industry

Identifiers

NCT07018635

INCB161734-103

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

Cohort 1

Experimental group

Description:

INCB161734 and itraconazole will be administered at protocol defined doses.

Treatment:

Drug: INCB161734

Drug: Itraconazole

Cohort 2

Experimental group

Description:

INCB161734 and rifampin will be administered at protocol defined doses.

Treatment:

Drug: INCB161734

Drug: Rifampin

Cohort 3

Experimental group

Description:

INCB161734 and esomeprazole will be administered at protocol defined doses.

Treatment:

Drug: Esomeprazole

Drug: INCB161734

Cohort 4

Experimental group

Description:

INCB161734 and famotidine will be administered at protocol defined doses.

Treatment:

Drug: INCB161734

Drug: Famotidine