CClinicalTrials.gg
CompletedNCT03224260Updated Jun 1, 2018

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

A Phase 1 interventional study of BMS-986177 and Matched Placebo in Thrombosis, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-01.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Nov 2017, 8 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Thrombosis

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03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 33 is below the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Treatment A

    Receive 50 mg BMS-986177 once daily or placebo

    Drug: BMS-986177 · Other: Matched Placebo

  • Experimental
    Treatment B

    Receive 200 mg BMS-986177 once daily or placebo

    Drug: BMS-986177 · Other: Matched Placebo

  • Experimental
    Treatment C

    Receive 500 mg BMS-986177 once daily or placebo

    Drug: BMS-986177 · Other: Matched Placebo

Interventions

  • DrugBMS-986177

    Oral Suspension

  • OtherMatched Placebo

    Oral Suspension

06

What researchers measure

Primary outcomes

  1. Occurrence of Death

    Measured by investigator assessment

    Time frame: 30 days after last dose

  2. Incidence of Serious Adverse Events (SAEs)

    Measured by investigator assessment

    Time frame: 30 days after last dose

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

    Measured by investigator assessment

    Time frame: 17 days

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

    Measured by investigator assessment

    Time frame: 17 days

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

    Measured by investigator assessment

    Time frame: 17 days

  6. Change from baseline in electrocardiogram findings (ECGs)

    Measured by investigator assessment

    Time frame: 17 days

07

Study locations

1 site
  • West Coast Clinical Trials
    Anaheim, California 90630, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03224260
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jul 21, 2017
Start date
Jun 28, 2017
Primary completion
Nov 7, 2017
Completion
Nov 7, 2017
Last update
Jun 1, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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