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

NCT01708889 | Completed Phase 1

• 1 other identifier: AI452-019
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Chronic Hepatitis B Virus Infection; Chronic Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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

Study Arms (5)

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

Biological: BMS-914143 (Peginterferon Lambda-1a)

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

Biological: BMS-914143 (Peginterferon Lambda-1a)

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

Biological: BMS-914143 (Peginterferon Lambda-1a)

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

Biological: BMS-914143 (Peginterferon Lambda-1a)

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

EXPERIMENTAL

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)

Interventions

BMS-914143 (Peginterferon Lambda-1a) BIOLOGICAL

Also known as: Lambda

Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2); Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2); Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2); Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2); Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Clinical Pharmacology Of Miami Inc.

Miami, Florida, 33014-3616, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

New Orleans Center For Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon lambda-1a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 17, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (3)