Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.

Detailed Description
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Primary purpose: Protocol designed to evaluate the effect of renal impairment on pharmacokinetics of BMS-914143

Official Title
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An Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-914143 in Subject With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction

Conditions
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Chronic Hepatitis B Virus Infection, Chronic Hepatitis C Virus Infection

Intervention / Treatment
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* Biological: BMS-914143 (Peginterferon Lambda-1a)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal renal function or mild, moderate, severe or end-stage renal dysfunction Exclusion Criteria: History of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6 months of Lambda administration History of chronic liver disease including cirrhosis, hepatitis B virus (HBV), hepatitis C virus (HCV), primary biliary cirrhosis, etc History of central nervous system or neuro-psychiatric disease. Subjects with severe depression and/or other uncontrolled psychiatric conditions should not be enrolled in this study History of of suicide attempt within the 5 years preceding BMS-914143 administration Inability to tolerate subcutaneous injections Donation of >400 mL of blood within 8 weeks or plasma within 4 weeks of planned dosing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)<br>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 | Biological: BMS-914143 (Peginterferon Lambda-1a)<br> <br> * Other names: Lambda;|
| Experimental: Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2)<br>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 | Biological: BMS-914143 (Peginterferon Lambda-1a)<br> <br> * Other names: Lambda;|
| Experimental: Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2)<br>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 | Biological: BMS-914143 (Peginterferon Lambda-1a)<br> <br> * Other names: Lambda;|
| Experimental: Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2)<br>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 | Biological: BMS-914143 (Peginterferon Lambda-1a)<br> <br> * Other names: Lambda;|
| Experimental: Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2)<br>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) | Biological: BMS-914143 (Peginterferon Lambda-1a)<br> <br> * Other names: Lambda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |