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

Bristol-Myers Squibb1 site in 1 country56 target enrollmentOctober 4, 2016

ConditionsHeart Decompensation, Acute

InterventionsBMS-986231 BMS-986231 Placebo

DrugsBMS-986231 BMS-986231 Placebo

Overview

Phase: Phase 1
Intervention: BMS-986231
Conditions: Heart Decompensation, Acute
Sponsor: Bristol-Myers Squibb
Enrollment: 56
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 4, 2016

End Date

May 26, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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