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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-02-28

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.

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Detailed Description

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

Conditions

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Chronic Hepatitis B Virus Infection Chronic Hepatitis C Virus Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)

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 Type EXPERIMENTAL

BMS-914143 (Peginterferon Lambda-1a)

Intervention Type BIOLOGICAL

Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2)

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 Type EXPERIMENTAL

BMS-914143 (Peginterferon Lambda-1a)

Intervention Type BIOLOGICAL

Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2)

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 Type EXPERIMENTAL

BMS-914143 (Peginterferon Lambda-1a)

Intervention Type BIOLOGICAL

Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2)

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 Type EXPERIMENTAL

BMS-914143 (Peginterferon Lambda-1a)

Intervention Type BIOLOGICAL

Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2)

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)

Group Type EXPERIMENTAL

BMS-914143 (Peginterferon Lambda-1a)

Intervention Type BIOLOGICAL

Interventions

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BMS-914143 (Peginterferon Lambda-1a)

Intervention Type BIOLOGICAL

Other Intervention Names

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Lambda

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes