A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: BMS-986278; Drug: Sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT05684289

IM027-1017

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of BMS-986278 in healthy adult participants and Japanese participants.

Enrollment: 61 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants in the Japanese cohort (Part 2) must be first generation Japanese (born in Japan, not living outside of Japan > 10 years, both parents ethnically Japanese).
• Body mass index (BMI) of 18.0 kilogram (kg)/meter (m)^2 through 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2.
• Body weight ≥ 50 kg for males and ≥ 45 kg for females.

Exclusion criteria

• Any significant acute or chronic medical illness.
• Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion.
• Any major surgery within 4 weeks of first study intervention administration.

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 4 patient groups, including a placebo group

Part 1: BMS-986278 + Sildenafil

Experimental group

Treatment:

Drug: BMS-986278

Drug: Sildenafil

Part 1: Placebo + Sildenafil

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Sildenafil

Part 2: BMS-986278

Experimental group

Treatment:

Drug: BMS-986278

Part 2: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo