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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2017-11-07

Brief Summary

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

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Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

Receive 50 mg BMS-986177 once daily or placebo

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Oral Suspension

Matched Placebo

Intervention Type OTHER

Oral Suspension

Treatment B

Receive 200 mg BMS-986177 once daily or placebo

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Oral Suspension

Matched Placebo

Intervention Type OTHER

Oral Suspension

Treatment C

Receive 500 mg BMS-986177 once daily or placebo

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Oral Suspension

Matched Placebo

Intervention Type OTHER

Oral Suspension

Interventions

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BMS-986177

Oral Suspension

Intervention Type DRUG

Matched Placebo

Oral Suspension

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes