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

Phase 1

Completed

• Conditions: Heart Decompensation, Acute
• Interventions: Drug: BMS-986231; Drug: BMS-986231 Placebo

• Registration Number: NCT02932969
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-04
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-13
• Status Verified: 2017-05
• Primary Completion: 2017-05-26
• Study Completion: 2017-05-26
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Panel 1 Arm	BMS-986231 Placebo	BMS-986231 and BMS-986231 Placebo intravenously
Panel 3 Arm	BMS-986231 Placebo	BMS-986231 and BMS-986231 Placebo intravenously
Panel 2 Arm	BMS-986231 Placebo	BMS-986231 and BMS-986231 Placebo intravenously
Panel 1 Arm	BMS-986231	BMS-986231 and BMS-986231 Placebo intravenously
Panel 2 Arm	BMS-986231	BMS-986231 and BMS-986231 Placebo intravenously
Panel 3 Arm	BMS-986231	BMS-986231 and BMS-986231 Placebo intravenously

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

West Coast Clinical Trials, Llc; 🇺🇸 Cypress, California, United States