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

Chronic Hepatitis C Virus Infection Clinical Trial

— PK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708889
• Other study ID #: AI452-019
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2012
• Last updated: June 4, 2013
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Hepatitis B Virus Infection
• Chronic Hepatitis C Virus Infection
• Hepatitis
• Hepatitis A
• Hepatitis B, Chronic
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Renal Insufficiency
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
United States	New Orleans Center For Clinical Research - Knoxville	Knoxville	Tennessee
United States	Clinical Pharmacology Of Miami Inc.	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Time to maximum observed serum concentration (Tmax) using serum levels of Lambda		18 time points up to Day 29	No
Secondary	Half life (T-HALF) using serum levels of Lambda		18 time points up to Day 29	No
Secondary	Immunogenicity assessed by serum levels of anti-Lambda antibodies		5 time points up to Day 43	No
Secondary	Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)		Up to Day 43	Yes
Secondary	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	Yes

External Links

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