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Business objectives have changed
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Specified dose on specified days |
|
| Arm B | Placebo Comparator | Specified dose on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAEs) | Up to one month | |
| Number of Adverse Events (AEs) | Up to one month | |
| Number of deaths | Up to one month |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to one month | |
| Time of maximum observed plasma concentration (Tmax) | Up to one month | |
| Terminal elimination half-life (T-HALF) |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Healthy Subjects (Part A and B)
Heart Failure Patients (Part C)
Exclusion Criteria:
Healthy Subjects (Part A and B)
Heart Failure Patients (Part C)
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vseobecna Fakultni Nemocnice v Praze | Prague | 12808 | Czechia | |||
| Krajska zdravotni - Masarykova nemocnice v Usti nad Labem |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| BMS-986224 |
| Drug |
Specified dose on specified days |
|
| Up to one month |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to one month |
| Area under the plasma concentration-time curve from time zero extrapoloated [AUC(INF)] | Up to one month |
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] | Up to one month |
| Accumulation ratio: ratio of Cmax following last dose to Cmax following first dose (ARcmax) | Up to one month |
| Accumulation ratio: ratio of AUC(TAU) following last dose to AUC(TAU) following first dose (ARtau) | Up to one month |
| Terminal elimination rate constant (kel) | Up to one month |
| Apparent oral clearance, calculated as dose/AUC(INF) for single dose or dose/AUC(TAU) for multiple dose | Up to one month |
| Apparent volume of distribution at terminal phase (Vz/F) | Up to one month |
| Cumulative urinary excretion (of the unchanged drug) over one dosing interval [Ae(TAU)] | Up to one month |
| Cumulative urinary excretion (of the unchanged drug) [Aet] | Up to one month |
| Renal clearance (CLr) | Up to one month |
| Amount excreted unchanged (%) [UR%] | Up to one month |
| Ratio of Metabolite Cmax to Parent Cmax, corrected for molecular weight (MR_Cmax) | Up to one month |
| Ratio of Metabolite AUC(INF) to Parent AUC(INF), corrected for molecular weight | Up to one month |
| Ratio of Metabolite AUC(0-T) to Parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)] | Up to one month |
| Ratio of Metabolite AUC(TAU) to Parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] | Up to one month |
| Drug-drug interaction (DDI) assessment | Up to one month |
| Ústí nad Labem |
| 401 13 |
| Czechia |
| Deventer Ziekenhuis | Deventer | 7416 SE | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| PRA Health Sciences - Groningen | Groningen | 9728 NZ | Netherlands |
| Spaarne Gasthuis - Haarlem-Zuid | Haarlem | 2035 RC | Netherlands |
| D & A Research and Genetics | Sneek | 8601 ZR | Netherlands |
| Samodzielny Publiczny Szpital Kliniczny Number 4 w Lublinie | Lublin | 20-954 | Poland |
| 4th Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Wroclaw | 50-981 | Poland |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Alvaro Cunqueiro | Vigo | 36312 | Spain |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2TH | United Kingdom |
| NHS Tayside | Dundee | DD1 9SY | United Kingdom |
| The University of Edinburgh | Edinburgh | EH16 4SB | United Kingdom |
| Richmond Pharmacology | London | United Kingdom |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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