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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Heart Decompensation, Acute

Treatments: Drug: BMS-986231; Drug: BMS-986231 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02932969

CV013-018

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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56 participants in 3 patient groups

Panel 1 Arm

Experimental group

Description:

BMS-986231 and BMS-986231 Placebo intravenously

Treatment:

Drug: BMS-986231 Placebo

Drug: BMS-986231

Panel 2 Arm

Experimental group

Description:

BMS-986231 and BMS-986231 Placebo intravenously

Treatment:

Drug: BMS-986231 Placebo

Drug: BMS-986231

Panel 3 Arm

Experimental group

Description:

BMS-986231 and BMS-986231 Placebo intravenously

Treatment:

Drug: BMS-986231 Placebo

Drug: BMS-986231