Study With Healthy Japanese and Non-Asian Participants With BMS-986231
A Randomized, Double-Blind, Placebo-controlled, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Japanese and Non- Asian Participants
1 other identifier
interventional
56
1 country
1
Brief Summary
The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.
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 Oct 2016
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2017
CompletedMay 31, 2017
May 1, 2017
8 months
October 12, 2016
May 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of single continuous IV infusion of BMS-986231 in healthy Japanese and Non-Asian participants based on Adverse events, clinical laboratory values, vital signs, ECGs, and physical examinations
11 days
Study Arms (3)
Panel 1 Arm
EXPERIMENTALBMS-986231 and BMS-986231 Placebo intravenously
Panel 2 Arm
EXPERIMENTALBMS-986231 and BMS-986231 Placebo intravenously
Panel 3 Arm
EXPERIMENTALBMS-986231 and BMS-986231 Placebo intravenously
Interventions
Eligibility Criteria
You may qualify if:
- Ancestry
- First generation Japanese
- Non-Asian with grandparents and parents of non-Asian descent
- Body weight greater than or equal to 45kg and less than or equal to 110kg
- Women of childbearing potential have specific birthcontrol methods
- Males sexually active with women of childbearing potential have specific birthcontrol methods
You may not qualify if:
- History of chronic illness
- Chronic headaches
- Recurrent dizziness
- Personal or family history of heart disease
- Personal history of bleeding diathesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Coast Clinical Trials, Llc
Cypress, California, 90630, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 13, 2016
Study Start
October 4, 2016
Primary Completion
May 26, 2017
Study Completion
May 26, 2017
Last Updated
May 31, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share