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OpenTrials
Completed

NCT Number: NCT03224260

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

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

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Coast Clinical Trials

Anaheim, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986177

Drug

Oral Suspension

Matched placebo

Other

Oral Suspension

Primary outcomes

  1. Occurrence of Death

    Time frame: 30 days after last dose

    Measured by investigator assessment

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: 30 days after last dose

    Measured by investigator assessment

  3. Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy

    Time frame: 17 days

    Measured by investigator assessment

  4. Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding

    Time frame: 17 days

    Measured by investigator assessment

  5. Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature)

    Time frame: 17 days

    Measured by investigator assessment

  6. Change from baseline in electrocardiogram findings (ECGs)

    Time frame: 17 days

    Measured by investigator assessment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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