Study With Healthy Japanese and Non-Asian Participants With BMS-986231
Primary Purpose
Heart Decompensation, Acute
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986231
BMS-986231 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Decompensation, Acute
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- History of chronic illness
- Chronic headaches
- Recurrent dizziness
- Personal or family history of heart disease
- Personal history of bleeding diathesis
Sites / Locations
- West Coast Clinical Trials, Llc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Panel 1 Arm
Panel 2 Arm
Panel 3 Arm
Arm Description
BMS-986231 and BMS-986231 Placebo intravenously
BMS-986231 and BMS-986231 Placebo intravenously
BMS-986231 and BMS-986231 Placebo intravenously
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02932969
Brief Title
Study With Healthy Japanese and Non-Asian Participants With BMS-986231
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
May 26, 2017 (Actual)
Study Completion Date
May 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Decompensation, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Panel 1 Arm
Arm Type
Experimental
Arm Description
BMS-986231 and BMS-986231 Placebo intravenously
Arm Title
Panel 2 Arm
Arm Type
Experimental
Arm Description
BMS-986231 and BMS-986231 Placebo intravenously
Arm Title
Panel 3 Arm
Arm Type
Experimental
Arm Description
BMS-986231 and BMS-986231 Placebo intravenously
Intervention Type
Drug
Intervention Name(s)
BMS-986231
Intervention Type
Drug
Intervention Name(s)
BMS-986231 Placebo
Primary Outcome Measure Information:
Title
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
Time Frame
11 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
History of chronic illness
Chronic headaches
Recurrent dizziness
Personal or family history of heart disease
Personal history of bleeding diathesis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
West Coast Clinical Trials, Llc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.bms.com/studyconnect/pages/home.aspx
Description
BMS Clinical Trial Education Resource
Learn more about this trial
Study With Healthy Japanese and Non-Asian Participants With BMS-986231
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