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

Bristol-Myers Squibb (BMS) logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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