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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03224260
Collaborator
(none)
33
Enrollment
1
Location
3
Arms
4.3
Actual Duration (Months)
7.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
Actual Study Start Date :
Jun 28, 2017
Actual Primary Completion Date :
Nov 7, 2017
Actual Study Completion Date :
Nov 7, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Occurrence of Death [30 days after last dose]

    Measured by investigator assessment

  2. Incidence of Serious Adverse Events (SAEs) [30 days after last dose]

    Measured by investigator assessment

  3. Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy [17 days]

    Measured by investigator assessment

  4. Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding [17 days]

    Measured by investigator assessment

  5. Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature) [17 days]

    Measured by investigator assessment

  6. Change from baseline in electrocardiogram findings (ECGs) [17 days]

    Measured by investigator assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 West Coast Clinical Trials Anaheim California United States 90630

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03224260
Other Study ID Numbers:
  • CV010-011
First Posted:
Jul 21, 2017
Last Update Posted:
Jun 1, 2018
Last Verified:
May 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thrombosis

Study Results

No Results Posted as of Jun 1, 2018