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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004914-24 | EudraCT Number |
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This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hepatic impairment | Experimental | Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points |
|
| Moderate hepatic impairment | Experimental | Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points |
|
| Severe hepatic impairment | Experimental | Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points |
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| Normal hepatic function | Experimental | Based on Hepatic Function Impairment as defined by the investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986231 | Drug | Intravenous (IV) administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration | Up to 2 days | |
| AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration | Up to 2 days | |
| Maximum plasma concentration (Cmax) | Up to 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AE) | Up to 33 days | |
| Incidence of serious adverse events (SAE) | Up to 33 days | |
| Incidence of Laboratory Test Result Abnormalities |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Semmelweis Egyetem Altalanos Orvostudomanyi Kar | Budapest | 1083 | Hungary | |||
| Clinical Research Unit Hungary |
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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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| Up to 11 days |
| Clearance (CL) derived from plasma concentration | Up to 2 days |
| Terminal elimination half-life (t1/2) derived from plasma concentration | Up to 2 days |
| Time of maximum observed plasma concentration (Tmax) | Up to 2 days |
| Terminal elimination phase rate constant (λz) derived from plasma concentration | Up to 2 days |
| Volume of distribution during terminal phase (Vz) derived from plasma concentration | Up to 2 days |
| Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration | Up to 2 days |
| Miskolc |
| 3529 |
| Hungary |
| BioVirtus Centrum Medyczne | Józefów | 05-410 | Poland |
| KO-MED Centra Kliniczne Lublin | Lublin | 20-954 | Poland |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D048550 | Hepatic Insufficiency |
| D017093 | Liver Failure |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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