A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction
NCT ID: NCT03281122
Last Updated: 2021-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
199 participants
INTERVENTIONAL
2017-09-22
2019-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Arm A
Specified dose on specified days
Placebo
Specified dose on specified days
BMS-986224
Specified dose on specified days
Arm B
Specified dose on specified days
Placebo
Specified dose on specified days
BMS-986224
Specified dose on specified days
Interventions
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Placebo
Specified dose on specified days
BMS-986224
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Vseobecna Fakultni Nemocnice v Praze
Prague, , Czechia
Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, , Czechia
Deventer Ziekenhuis
Deventer, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
PRA Health Sciences - Groningen
Groningen, , Netherlands
Spaarne Gasthuis - Haarlem-Zuid
Haarlem, , Netherlands
D & A Research and Genetics
Sneek, , Netherlands
Samodzielny Publiczny Szpital Kliniczny Number 4 w Lublinie
Lublin, , Poland
4th Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Wroclaw, , Poland
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Alvaro Cunqueiro
Vigo, , Spain
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
NHS Tayside
Dundee, , United Kingdom
The University of Edinburgh
Edinburgh, , United Kingdom
Richmond Pharmacology
London, , United Kingdom
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CV016-007
Identifier Type: -
Identifier Source: org_study_id
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