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

Phase 1

Completed

• Conditions: Chronic Hepatitis B Virus Infection; Chronic Hepatitis C Virus Infection
• Interventions: Biological: BMS-914143 (Peginterferon Lambda-1a)

• Registration Number: NCT01708889
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Normal renal function or mild, moderate, severe or end-stage renal dysfunction

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)	BMS-914143 (Peginterferon Lambda-1a)	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)	BMS-914143 (Peginterferon Lambda-1a)	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)	BMS-914143 (Peginterferon Lambda-1a)	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)	BMS-914143 (Peginterferon Lambda-1a)	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)	BMS-914143 (Peginterferon Lambda-1a)	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

New Orleans Center For Clinical Research - Knoxville; 🇺🇸 Knoxville, Tennessee, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Clinical Pharmacology Of Miami Inc.; 🇺🇸 Miami, Florida, United States