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Completed

NCT Number: NCT01708889

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

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Of Miami Inc., Miami, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-914143 (Peginterferon Lambda-1a)

Biological

Other names: Lambda

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Time to maximum observed serum concentration (Tmax) using serum levels of Lambda

    Time frame: 18 time points up to Day 29

  2. Half life (T-HALF) using serum levels of Lambda

    Time frame: 18 time points up to Day 29

  3. Immunogenicity assessed by serum levels of anti-Lambda antibodies

    Time frame: 5 time points up to Day 43

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: PK

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2012
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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