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The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.
Primary purpose: Protocol designed to evaluate the effect of renal impairment on pharmacokinetics of BMS-914143
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2) | Experimental | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with normal renal function with eGFR ≥ 80 mL/min/1.73 m2 |
|
| Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2) | Experimental | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with mild renal dysfunction with eGFR 60 to 79 mL/min/1.73 m2 |
|
| Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2) | Experimental | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with moderate renal dysfunction with eGFR 30 to 59 mL/min/1.73 m2 |
|
| Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2) | Experimental | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with severe renal dysfunction with eGFR 15 to 29 mL/min/1.73 m2 |
|
| Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-914143 (Peginterferon Lambda-1a) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction | 18 time points up to Day 29 | |
| Area under the serum concentration-time curve from time 0 to the time of last quantifiable concentration [AUC(0-T)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction | 18 time points up to Day 29 | |
| Maximum observed serum concentration (Cmax) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction | 18 time points up to Day 29 | |
| Apparent volume of distribution (Vz/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction | 18 time points up to Day 29 | |
| Total body clearance (CLT/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction | 18 time points up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed serum concentration (Tmax) using serum levels of Lambda | 18 time points up to Day 29 | |
| Half life (T-HALF) using serum levels of Lambda | 18 time points up to Day 29 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Of Miami Inc. | Miami | Florida | 33014-3616 | United States | ||
| Orlando Clinical Research Center |
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BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with end-stage renal dysfunction with eGFR < 15 mL/min/1.73 m2 (on hemodialysis [HD] or non-HD) |
|
|
| Immunogenicity assessed by serum levels of anti-Lambda antibodies |
| 5 time points up to Day 43 |
| Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs) | Up to Day 43 |
| Serious adverse events (SAEs) Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs) | Approximately up to Day 73 |
| Orlando |
| Florida |
| 32809 |
| United States |
| New Orleans Center For Clinical Research - Knoxville | Knoxville | Tennessee | 37920 | United States |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000600496 | peginterferon lambda-1a |
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