Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: [14C] BMS-986278

Drug: Kinevac®

Study type

Interventional

Funder types

Industry

Identifiers

NCT04567667

IM027-048

Details and patient eligibility

About

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.

Enrollment

9 patients

Sex

Male

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations
Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height [m])2
Males must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
Any major surgery within 6 weeks of study treatment administration

Other protocol-defined inclusion/exclusion criteria apply