Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants

Last updated: March 4, 2025
Sponsor: Celgene
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

BMS-986365

Rabeprazole

Clinical Study ID

NCT06417229
CA228-1011
  • Ages 18-60
  • Male
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy adult male participants as determined by no clinically significantdeviations from normal in medical history, physical examination, vital signs, ECGs,echocardiogram, or clinical laboratory assessments as determined by theinvestigator.

  • Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive.

Exclusion

Exclusion Criteria:

  • Any significant acute or chronic illness.

  • Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias,or prolonged QT interval.

  • History of allergy/hypersensitivity to any component (including excipients) ofBMS-986365 study interventions or related compounds.

  • Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: BMS-986365
Phase: 1
Study Start date:
May 28, 2024
Estimated Completion Date:
February 19, 2025

Connect with a study center

  • ICON Lenexa

    Lenexa, Kansas 66219
    United States

    Active - Recruiting

  • Local Institution - 0001

    Lenexa, Kansas 66219
    United States

    Site Not Available

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