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

Phase 1CompletedNCT01708889

Bristol-Myers Squibb43 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B Virus Infection Chronic Hepatitis C Virus Infection

Interventions

BMS-914143 (Peginterferon Lambda-1a)BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Clinical Pharmacology Of Miami Inc.

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

New Orleans Center For Clinical Research - Knoxville

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

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