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

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986177
Matched Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thrombosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • West Coast Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Treatment A

Treatment B

Treatment C

Arm Description

Receive 50 mg BMS-986177 once daily or placebo

Receive 200 mg BMS-986177 once daily or placebo

Receive 500 mg BMS-986177 once daily or placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 18, 2017
Last Updated
May 30, 2018
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03224260
Brief Title
To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
Official Title
Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
November 7, 2017 (Actual)
Study Completion Date
November 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Experimental
Arm Description
Receive 50 mg BMS-986177 once daily or placebo
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Receive 200 mg BMS-986177 once daily or placebo
Arm Title
Treatment C
Arm Type
Experimental
Arm Description
Receive 500 mg BMS-986177 once daily or placebo
Intervention Type
Drug
Intervention Name(s)
BMS-986177
Intervention Description
Oral Suspension
Intervention Type
Other
Intervention Name(s)
Matched Placebo
Intervention Description
Oral Suspension
Primary Outcome Measure Information:
Title
Occurrence of Death
Description
Measured by investigator assessment
Time Frame
30 days after last dose
Title
Incidence of Serious Adverse Events (SAEs)
Description
Measured by investigator assessment
Time Frame
30 days after last dose
Title
Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy
Description
Measured by investigator assessment
Time Frame
17 days
Title
Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding
Description
Measured by investigator assessment
Time Frame
17 days
Title
Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature)
Description
Measured by investigator assessment
Time Frame
17 days
Title
Change from baseline in electrocardiogram findings (ECGs)
Description
Measured by investigator assessment
Time Frame
17 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
West Coast Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
90630
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/safety/recalls/
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS clinical trial educational resource

Learn more about this trial

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

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