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OpenTrials
Completed

NCT Number: NCT06433505

A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants

The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
  • Participants will require a left ventricular ejection fraction of > 50% at screening.
  • Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height [m])2.

Exclusion criteria

  • Any current or recent significant acute or chronic illness.
  • Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (> 450 ms) at screening.
  • Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.
  • History of allergy to BMS-986365 or related compounds.

Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986365

Drug

Specified dose on specified days

[14C] BMS-986365

Drug

Specified dose on specified days.

[14C] BMS-986409 + BMS-986410

Drug

Specified dose on specified days

[14C] BMS-986410 + BMS-986409

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Day 60

    Part A and B

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 60

    Part A and B

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

    Time frame: Up to Day 60

    Part A and B

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

    Time frame: Up to Day 60

    Part A and B

  5. Apparent terminal plasma half-life (T-HALF)

    Time frame: Up to Day 60

    Part A and B

  6. Total body clearance (CLT)

    Time frame: Up to Day 15

    Part A

  7. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 60

    Part A and B

  8. Mean residence time (MRT)

    Time frame: Up to Day 15

    Part A

  9. Apparent volume of distribution (Vz)

    Time frame: Up to Day 15

    Part A

  10. Apparent volume of distribution (Vz/F)

    Time frame: Up to Day 60

    Part A and B

  11. Absolute bioavailability (F)

    Time frame: Up to Day 15

    Part A

Secondary outcomes

  1. Number of participants with Adverse Events

    Time frame: Up to Day 60

    Part A and B

  2. Number of participants with Serious Adverse Events

    Time frame: Up to Day 60

    Part A and B

  3. Number of participants with AEs leading to discontinuation

    Time frame: Up to Day 60

    Part A and B

  4. Number of participants with Vital sign abnormalities

    Time frame: Up to Day 60

    Part A and B

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 60

    Part A and B

  6. Number of participants with physical examination abnormalities

    Time frame: Up to Day 60

    Part A and B

  7. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 60

    Part A and B

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 29, 2024
Registry last updated
Mar 26, 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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