Status:
TERMINATED
A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Heart Failure
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2019
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT03281122
Start Date
September 22 2017
End Date
April 17 2019
Last Update
February 25 2021
Active Locations (18)
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1
Vseobecna Fakultni Nemocnice v Praze
Prague, Czechia, 12808
2
Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, Czechia, 401 13
3
Deventer Ziekenhuis
Deventer, Netherlands, 7416 SE
4
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ