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

NCT ID: NCT06170723

Last Updated: 2024-07-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2024-05-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: BMS-986368 - Fasted

Group Type EXPERIMENTAL

BMS-986368

Intervention Type DRUG

Specified dose on specified days

Part 1: Itraconazole - Fasted

Group Type EXPERIMENTAL

Itraconazole

Intervention Type DRUG

Specified dose on specified days

Part 1: BMS-986368 with Itraconazole - Fasted

Group Type EXPERIMENTAL

BMS-986368

Intervention Type DRUG

Specified dose on specified days

Itraconazole

Intervention Type DRUG

Specified dose on specified days

Part 2: BMS-986368 - Fasted

Group Type EXPERIMENTAL

BMS-986368

Intervention Type DRUG

Specified dose on specified days

Part 2: BMS-986368 - Fed

Group Type EXPERIMENTAL

BMS-986368

Intervention Type DRUG

Specified dose on specified days

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

Group Type EXPERIMENTAL

BMS-986368

Intervention Type DRUG

Specified dose on specified days

Famotidine

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986368

Specified dose on specified days

Intervention Type DRUG

Itraconazole

Specified dose on specified days

Intervention Type DRUG

Famotidine

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Tempe, Arizona, United States

Site Status

Countries

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United States

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

Other Identifiers

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IM045-1002

Identifier Type: -

Identifier Source: org_study_id

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