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Completed

NCT Number: NCT06417229

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator.
  • Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive.

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) of BMS-986365 study interventions or related compounds.
  • Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986365

Drug

Specified dose on specified days

Other names: CC-94676

rabeprazole

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 75

  2. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]

    Time frame: Up to Day 75

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

    Time frame: Up to Day 75

Secondary outcomes

  1. To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation

    Time frame: Up to Day 75

  2. Incidence of adverse events (AE)

    Time frame: Up to Day 75

  3. Incidence of serious adverse events (SAE)

    Time frame: Up to Day 75

  4. Number of participants with physical examination abnormalities

    Time frame: Up to Day 75

  5. Number of participants with vital sign abnormalities

    Time frame: Up to Day 75

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 75

  7. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 75

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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