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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
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Decompensation, Acute

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 12, 2016
Last Updated
May 30, 2017
Sponsor
Bristol-Myers Squibb
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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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