Facebook Icon Print Created with Sketch. Twitter Icon Created with Sketch. Created with Sketch. LinkedIn Icon Green Check Icon Created with Sketch. YouTube Icon Right Arrow Icon Mobile Menu Icon Chevron Right Icon Phone Icon Health Study Area: AutoImmune Disease Health Study Area: Blood Cancer Health Study Area: Cardiovascular Disease Health Study Area: Fibrosis Health Study Area: Gastrointestinal Cancer Health Study Area: Genitourinary Health Study Area: Head and Neck Cancer Health Study Area: Lung Cancer Health Study Area: Melanoma For Caregivers For Clinicians Communities FAQs For Parents For Patients Chevron Icon Bookmark Icon Map Icon Share Icon Direction Arrow Icon Direction Arrow Icon Page Icon Location Icon Search Icon External Link Icon Help Icon Error Icon Glossary Email Icon Gender Both Gender Male Gender Female Created with Sketch. Created with Sketch.

Please Log In/Join Now first, and then use this function!

Recruiting

A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction - CV016-007

Updated: 05 November, 2018   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-55

    Age Range

  • 10

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A
Drug: Placebo Drug: BMS-986224
Placebo Comparator: Arm B
Drug: BMS-986224 Drug: Placebo

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy Subjects (Part A and B) - Healthy subjects, as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations - Subjects must be willing and able to complete all study-specific procedures and visits - Additional criterion for Japanese subjects in Groups BJ1 to BJ3: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for > 10 years, and both parents are ethnically Japanese) Heart Failure Patients (Part C) - Left ventricular EF <45% and >25%, as assessed by cardiac MRI within 3 months of first dose of study drug; or left ventricular EF <40% and >25% as assessed by echocardiogram at Screening or within 3 months of first dose of study drug; left ventricular EF - Heart failure is considered to be stable at the discretion of the Investigator (i.e., no acute cardiovascular [CV] events or hospitalization (including emergency room visits) for CV causes within 3 months of first dose of study drug - Regular sinus rhythm at Screening and no history of atrial fibrillation in the past 12 months Exclusion Criteria: Healthy Subjects (Part A and B) - Major surgery within 4 weeks of (first) study treatment administration - Inability to be venipunctured and/or tolerate venous access - Subjects who have smoked or used smoking cessation or nicotine containing products (including, but not limited, to e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum, varenicline, bupropion) within 6 months of the first dose of study drug Heart Failure Patients (Part C) - Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption - Major surgery within 4 weeks of (first) study treatment administration - Inability to be venipunctured and/or tolerate venous access Other protocol defined inclusion/exclusion criteria could apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us