Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Heart Decompensation, Acute

Treatments: Drug: BMS-986231

Study type: Interventional

Funder types: Industry

Identifiers

NCT03210909

CV013-022

Details and patient eligibility

About

An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231

Enrollment: 5 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed Informed Consent
• Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
• Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.

Exclusion criteria

• History of chronic illness
• Chronic headaches
• Recurrent dizziness
• Personal or family history of heart disease
• Personal history of bleeding diathesis

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

BMS-986231 Intravenous Infusion

Experimental group

Description:

A single continuous intravenous infusion of BMS-986231

Treatment:

Drug: BMS-986231