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

Last updated: June 27, 2024
Sponsor: Celgene
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Itraconazole

Famotidine

BMS-986368

Clinical Study ID

NCT06170723
IM045-1002
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Personal or first-degree family history of clinically significant psychiatricdisorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder,generalized anxiety disorder, obsessive-compulsive disorder, and post-traumaticstress disorder. Situational depression, or anxiety in the past, may be enrolled atthe discretion of the investigator.

  • Participant has an active or prior history of stroke, chronic seizures, or majorneurological disorders or has first-degree family relative who was diagnosed withthese disorders below the age of 65 years.

  • Participant has a history of syncope and/or symptomatic orthostatic hypotension inthe year prior to Day 1.

Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 32
Treatment Group(s): 3
Primary Treatment: Itraconazole
Phase: 1
Study Start date:
March 18, 2024
Estimated Completion Date:
May 25, 2024

Connect with a study center

  • Celerion

    Tempe, Arizona 85283
    United States

    Active - Recruiting

  • Local Institution - 0001

    Tempe, Arizona 85283
    United States

    Site Not Available

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