To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: BMS-986177; Other: Matched Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03224260

CV010-011

Details and patient eligibility

About

Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered.

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must be first-generation Japanese (born in Japan and not living outside of Japan for > 10 years; both parents must be ethnically Japanese)
• Body Mass Index 18.0 to 25.0 kg/m2, inclusive
• Women must not be of nonchildbearing potential (cannot become pregnant)

Exclusion criteria

• Any significant acute or chronic medical illness
• History of allergy to BMS-986177 or other factor Xia inhibitors and/or formulation excipients or history of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
• History or evidence of abnormal bleeding or coagulation disorder

Other protocol defined inclusion and exclusion criteria apply

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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33 participants in 3 patient groups

Treatment A

Experimental group

Description:

Receive 50 mg BMS-986177 once daily or placebo

Treatment:

Other: Matched Placebo

Drug: BMS-986177

Treatment B

Experimental group

Description:

Receive 200 mg BMS-986177 once daily or placebo

Treatment:

Other: Matched Placebo

Drug: BMS-986177

Treatment C

Experimental group

Description:

Receive 500 mg BMS-986177 once daily or placebo

Treatment:

Other: Matched Placebo

Drug: BMS-986177