A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants

Celgene

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Famotidine; Drug: BMS-986368; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06170723

IM045-1002

Details and patient eligibility

About

This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) to 33.0 kg/m^2, inclusive.

Exclusion criteria

• Personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Situational depression, or anxiety in the past, may be enrolled at the discretion of the investigator.
• Participant has an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
• Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 6 patient groups

Part 1: BMS-986368 - Fasted

Experimental group

Treatment:

Drug: BMS-986368

Part 1: Itraconazole - Fasted

Experimental group

Treatment:

Drug: Itraconazole

Part 1: BMS-986368 with Itraconazole - Fasted

Experimental group

Treatment:

Drug: Itraconazole

Drug: BMS-986368

Part 2: BMS-986368 - Fasted

Experimental group

Treatment:

Drug: BMS-986368

Part 2: BMS-986368 - Fed

Experimental group

Treatment:

Drug: BMS-986368

Part 2: Famotidine, followed by BMS-986368 - Fasted

Experimental group

Treatment:

Drug: BMS-986368

Drug: Famotidine