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

Celgene

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: [14C] BMS-986365; Drug: [14C] BMS-986410 + BMS-986409; Drug: BMS-986365; Drug: [14C] BMS-986409 + BMS-986410

Study type: Interventional

Funder types: Industry

Identifiers

NCT06433505

CA071-1005

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Part A

Experimental group

Treatment:

Drug: BMS-986365

Drug: [14C] BMS-986365

Part B - Arm 1

Experimental group

Treatment:

Drug: [14C] BMS-986409 + BMS-986410

Part B - Arm 2

Experimental group

Treatment:

Drug: [14C] BMS-986410 + BMS-986409