To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
1 other identifier
interventional
33
1 country
1
Brief Summary
Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2017
CompletedFirst Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2017
CompletedJune 1, 2018
May 1, 2018
4 months
July 18, 2017
May 30, 2018
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (3)
Treatment A
EXPERIMENTALReceive 50 mg BMS-986177 once daily or placebo
Treatment B
EXPERIMENTALReceive 200 mg BMS-986177 once daily or placebo
Treatment C
EXPERIMENTALReceive 500 mg BMS-986177 once daily or placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Coast Clinical Trials
Anaheim, California, 90630, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2017
First Posted
July 21, 2017
Study Start
June 28, 2017
Primary Completion
November 7, 2017
Study Completion
November 7, 2017
Last Updated
June 1, 2018
Record last verified: 2018-05