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 |
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
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
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