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

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.

Completed

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Key information

Conditions

Heart Decompensation, Acute Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Coast Clinical Trials, Llc

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986231

Drug

BMS-986231 Placebo

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Oct 13, 2016
Registry last updated: May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed