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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 55
Updated:5/30/2018
Start Date:September 22, 2017
End Date:May 21, 2019
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email

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A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986224 in Healthy Subjects and Chronic Heart Failure Patients With Reduced Ejection Fraction

The purpose of this study is test the safety and tolerability of BMS-986224 and its effects
on the body in healthy subjects and subjects with chronic heart failure with reduced ejection
fraction


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
We found this trial at
2
sites
Salt Lake City, Utah 84132
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from
Salt Lake City, UT
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Praha 2, 12808
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from
Praha 2,
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