Heart Failure Clinical Trial
Official title:
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
Verified date | February 2021 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 199 |
Est. completion date | April 17, 2019 |
Est. primary completion date | April 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Vseobecna Fakultni Nemocnice v Praze | Praha 2 | |
Czechia | Krajska zdravotni - Masarykova nemocnice v Usti nad Labem | Usti nad Labem | |
Netherlands | Deventer Ziekenhuis | Deventer | |
Netherlands | PRA Health Sciences - Groningen | Groningen | |
Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
Netherlands | Spaarne Gasthuis - Haarlem-Zuid | Haarlem | |
Netherlands | D & A Research and Genetics | Sneek | |
Poland | Samodzielny Publiczny Szpital Kliniczny Number 4 w Lublinie | Lublin | |
Poland | 4th Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Wroclaw | |
Spain | Hospital Universitario Fundacion Jimenez Diaz | Madrid | |
Spain | Hospital Universitario Ramon Y Cajal | Madrid | |
Spain | Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
Spain | Hospital Alvaro Cunqueiro | Vigo | |
United Kingdom | University Hospitals Birmingham NHS Foundation Trust | Birmingham | |
United Kingdom | NHS Tayside | Dundee | |
United Kingdom | The University of Edinburgh | Edinburgh | |
United Kingdom | Richmond Pharmacology | London |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Czechia, Netherlands, Poland, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Serious Adverse Events (SAEs) | Up to one month | ||
Primary | Number of Adverse Events (AEs) | Up to one month | ||
Primary | Number of deaths | Up to one month | ||
Secondary | Maximum observed plasma concentration (Cmax) | Up to one month | ||
Secondary | Time of maximum observed plasma concentration (Tmax) | Up to one month | ||
Secondary | Terminal elimination half-life (T-HALF) | Up to one month | ||
Secondary | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to one month | ||
Secondary | Area under the plasma concentration-time curve from time zero extrapoloated [AUC(INF)] | Up to one month | ||
Secondary | Area under the concentration-time curve in one dosing interval [AUC(TAU)] | Up to one month | ||
Secondary | Accumulation ratio: ratio of Cmax following last dose to Cmax following first dose (ARcmax) | Up to one month | ||
Secondary | Accumulation ratio: ratio of AUC(TAU) following last dose to AUC(TAU) following first dose (ARtau) | Up to one month | ||
Secondary | Terminal elimination rate constant (kel) | Up to one month | ||
Secondary | Apparent oral clearance, calculated as dose/AUC(INF) for single dose or dose/AUC(TAU) for multiple dose | Up to one month | ||
Secondary | Apparent volume of distribution at terminal phase (Vz/F) | Up to one month | ||
Secondary | Cumulative urinary excretion (of the unchanged drug) over one dosing interval [Ae(TAU)] | Up to one month | ||
Secondary | Cumulative urinary excretion (of the unchanged drug) [Aet] | Up to one month | ||
Secondary | Renal clearance (CLr) | Up to one month | ||
Secondary | Amount excreted unchanged (%) [UR%] | Up to one month | ||
Secondary | Ratio of Metabolite Cmax to Parent Cmax, corrected for molecular weight (MR_Cmax) | Up to one month | ||
Secondary | Ratio of Metabolite AUC(INF) to Parent AUC(INF), corrected for molecular weight | Up to one month | ||
Secondary | Ratio of Metabolite AUC(0-T) to Parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)] | Up to one month | ||
Secondary | Ratio of Metabolite AUC(TAU) to Parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] | Up to one month | ||
Secondary | Drug-drug interaction (DDI) assessment | Up to one month |
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