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

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

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

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: BMS-986177
* Other: Matched Placebo


Participation Criteria
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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 Other protocol defined inclusion and exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Receive 50 mg BMS-986177 once daily or placebo | Drug: BMS-986177<br>* Oral Suspension<br>Other: Matched Placebo<br>* Oral Suspension<br>|
| Experimental: Treatment B<br>Receive 200 mg BMS-986177 once daily or placebo | Drug: BMS-986177<br>* Oral Suspension<br>Other: Matched Placebo<br>* Oral Suspension<br>|
| Experimental: Treatment C<br>Receive 500 mg BMS-986177 once daily or placebo | Drug: BMS-986177<br>* Oral Suspension<br>Other: Matched Placebo<br>* Oral Suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Death | Measured by investigator assessment | 30 days after last dose | 
| Incidence of Serious Adverse Events (SAEs) | Measured by investigator assessment | 30 days after last dose | 
| Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy | Measured by investigator assessment | 17 days | 
| Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding | Measured by investigator assessment | 17 days | 
| Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature) | Measured by investigator assessment | 17 days | 
| Change from baseline in electrocardiogram findings (ECGs) | Measured by investigator assessment | 17 days |