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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02932969

Enrollment

Registered

2016-10-13

Start date

2016-10-04

Completion date

2017-05-26

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Decompensation, Acute

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.

Interventions

DRUGBMS-986231

DRUGBMS-986231 Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026