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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02932969
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 3
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Decompensation, Acute	Drug: BMS-986231; Drug: BMS-986231 Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Oct 4, 2016
• Actual Primary Completion Date: May 26, 2017
• Actual Study Completion Date: May 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Panel 1 Arm BMS-986231 and BMS-986231 Placebo intravenously	Drug: BMS-986231; Drug: BMS-986231 Placebo
Experimental: Panel 2 Arm BMS-986231 and BMS-986231 Placebo intravenously	Drug: BMS-986231; Drug: BMS-986231 Placebo
Experimental: Panel 3 Arm BMS-986231 and BMS-986231 Placebo intravenously	Drug: BMS-986231; Drug: BMS-986231 Placebo

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Clinical Trials, Llc	Cypress	California	United States	90630

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Education Resource

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02932969
• Other Study ID Numbers: CV013-018
• First Posted: Oct 13, 2016
• Last Update Posted: May 31, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of May 31, 2017