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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986365; Drug: [14C] BMS-986365; Drug: [14C] BMS-986409 + BMS-986410; Drug: [14C] BMS-986410 + BMS-986409

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A	Drug: BMS-986365; Specified dose on specified days; Drug: [14C] BMS-986365; Specified dose on specified days.
Experimental: Part B - Arm 1	Drug: [14C] BMS-986409 + BMS-986410; Specified dose on specified days
Experimental: Part B - Arm 2	Drug: [14C] BMS-986410 + BMS-986409; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed concentration (Cmax)	Part A and B	Up to Day 60
Time of maximum observed concentration (Tmax)	Part A and B	Up to Day 60
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))	Part A and B	Up to Day 60
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))	Part A and B	Up to Day 60
Apparent terminal plasma half-life (T-HALF)	Part A and B	Up to Day 60
Total body clearance (CLT)	Part A	Up to Day 15
Apparent total body clearance (CLT/F)	Part A and B	Up to Day 60
Mean residence time (MRT)	Part A	Up to Day 15
Apparent volume of distribution (Vz)	Part A	Up to Day 15
Apparent volume of distribution (Vz/F)	Part A and B	Up to Day 60
Absolute bioavailability (F)	Part A	Up to Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events	Part A and B	Up to Day 60
Number of participants with Serious Adverse Events	Part A and B	Up to Day 60
Number of participants with AEs leading to discontinuation	Part A and B	Up to Day 60
Number of participants with Vital sign abnormalities	Part A and B	Up to Day 60
Number of participants with electrocardiogram (ECG) abnormalities	Part A and B	Up to Day 60
Number of participants with physical examination abnormalities	Part A and B	Up to Day 60
Number of participants with clinical laboratory abnormalities	Part A and B	Up to Day 60

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): February 14, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; ADME; CC-94676; Healthy Male Volunteers; Absolute Bioavailability; BMS-986365
• Other Study ID Numbers: CA071-1005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No