Study With Healthy Japanese and Non-Asian Participants With BMS-986231

Heart Decompensation, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932969
• Other study ID #: CV013-018
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2016
• Last updated: May 30, 2017
• Start date: October 4, 2016
• Est. completion date: May 26, 2017

Study information

• Verified date: May 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 26, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Decompensation, Acute
• Heart Failure

Intervention

Drug:
• BMS-986231

• BMS-986231 Placebo

Locations

Country	Name	City	State
United States	West Coast Clinical Trials, Llc	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   BMS Clinical Trial Education Resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form