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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001497-19 | EudraCT Number |
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This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Renal Impairment | Experimental | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
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| Moderate Renal Impairment | Experimental | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
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| Severe Renal Impairment | Experimental | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
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| Normal | Other | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986036 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036 | Up to 30 days | |
| Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036 | Up to 30 days | |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of C-terminal intact BMS-986036 | Up to 30 days | |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036 | Up to 30 days | |
| Terminal elimination half-life (T-half) of C-terminal intact BMS-986036 | Up to 30 days | |
| Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036 | Up to 30 days | |
| Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036 | Up to 30 days | |
| Total renal clearance (CLR) of C-terminal intact BMS-986036 | Up to 30 days | |
| Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036 | Up to 30 days | |
| Total amount excreted into urine (Ae) of C-terminal intact BMS-986036 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of total BMS-986036 | Up to 30 days | |
| Time of maximum observed serum concentration (Tmax) of total BMS-986036 | Up to 30 days | |
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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 |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates CZ, s.r.o | Prague | 170 00 | Czechia | |||
| PRA Magyarorszag Kft |
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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 30 days |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036 |
| Up to 30 days |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036 | Up to 30 days |
| Terminal elimination half-life (T-half) of total BMS-986036 | Up to 30 days |
| Apparent total body clearance (CLT/F) of total BMS-986036 | Up to 30 days |
| Apparent volume of distribution (Vz/F) of total BMS-986036 | Up to 30 days |
| Total renal clearance (CLR) of total BMS-986036 | Up to 30 days |
| Amount per fraction excreted into urine (Fe) of total BMS-986036 | Up to 30 days |
| Total amount excreted into urine (Ae) of total BMS-986036 | Up to 30 days |
| Incidence of injection site reactions (prospective) | Up to 30 days |
| Incidence of adverse events (AE) | Up to 30 days |
| Incidence of serious adverse events (SAE) | Up to 30 days |
| Incidence of clinically significant changes to events of special interest | Events of special interest include injection site assessment, AEs leading to discontinuation, and deaths as well as AEs related to marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiogram (ECGs), and physical examinations | Up to 30 days |
| Budapest |
| 1077 |
| Hungary |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Clinical Research Unit Hungary | Miskolc | 3529 | Hungary |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000630067 | Pegbelfermin |
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