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

May 30, 2018 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 90630
        • West Coast Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 28, 2017

Primary Completion (ACTUAL)

November 7, 2017

Study Completion (ACTUAL)

November 7, 2017

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (ACTUAL)

July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV010-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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