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

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Drug: BMS-986177; Other: Matched Placebo

• Registration Number: NCT03224260
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-28
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Primary Completion: 2017-11-07
• Study Completion: 2017-11-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Treatment C	Matched Placebo	Receive 500 mg BMS-986177 once daily or placebo
Treatment A	BMS-986177	Receive 50 mg BMS-986177 once daily or placebo
Treatment B	Matched Placebo	Receive 200 mg BMS-986177 once daily or placebo
Treatment C	BMS-986177	Receive 500 mg BMS-986177 once daily or placebo
Treatment A	Matched Placebo	Receive 50 mg BMS-986177 once daily or placebo
Treatment B	BMS-986177	Receive 200 mg BMS-986177 once daily or placebo

Primary Outcome Measures

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

Trial Locations

Locations (1)

West Coast Clinical Trials; 🇺🇸 Anaheim, California, United States