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

Bristol-Myers Squibb56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Decompensation, Acute

Interventions

BMS-986231DRUG

BMS-986231 PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

West Coast Clinical Trials, Llc

Cypress, California, United States

Outcomes

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

Data from ClinicalTrials.gov

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