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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01708889
First received: October 16, 2012
Last updated: February 7, 2013
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis B Virus Infection
Chronic Hepatitis C Virus Infection
 Biological: BMS-914143 (Peginterferon Lambda-1a)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 [ Time Frame: 18 time points up to Day 29 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 18 time points up to Day 29 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 18 time points up to Day 29 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 18 time points up to Day 29 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 18 time points up to Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to maximum observed serum concentration (Tmax) using serum levels of Lambda [ Time Frame: 18 time points up to Day 29 ] [ Designated as safety issue: No ]
  • Half life (T-HALF) using serum levels of Lambda [ Time Frame: 18 time points up to Day 29 ] [ Designated as safety issue: No ]
  • Immunogenicity assessed by serum levels of anti-Lambda antibodies [ Time Frame: 5 time points up to Day 43 ] [ Designated as safety issue: No ]
  • Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs) [ Time Frame: Up to Day 43 ] [ Designated as safety issue: Yes ]
  • Serious adverse events (SAEs) Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs) [ Time Frame: Approximately up to Day 73 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: September 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 Biological: BMS-914143 (Peginterferon Lambda-1a)
Other Name: Lambda
Experimental: 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
 Biological: BMS-914143 (Peginterferon Lambda-1a)
Other Name: Lambda
Experimental: 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
 Biological: BMS-914143 (Peginterferon Lambda-1a)
Other Name: Lambda
Experimental: 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
 Biological: BMS-914143 (Peginterferon Lambda-1a)
Other Name: Lambda
Experimental: 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)
 Biological: BMS-914143 (Peginterferon Lambda-1a)
Other Name: Lambda

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708889

Locations
United States, Florida
Clinical Pharmacology Of Miami Inc.
Miami, Florida, United States, 33014
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Tennessee
New Orleans Center For Clinical Research - Knoxville
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01708889     History of Changes
Other Study ID Numbers: AI452-019
Study First Received: October 16, 2012
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis C
Encephalitis, Herpes Simplex
Virus Diseases
Hepatitis B, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Herpesviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013