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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Heart Failure

Treatments: Drug: BMS-986224; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03281122

CV016-007

Details and patient eligibility

About

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

Enrollment: 199 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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199 participants in 2 patient groups, including a placebo group

Arm A

Experimental group

Description:

Specified dose on specified days

Treatment:

Drug: Placebo

Drug: BMS-986224

Arm B

Placebo Comparator group

Description:

Specified dose on specified days

Treatment:

Drug: Placebo

Drug: BMS-986224