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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01708889
Other study ID # AI452-019
Secondary ID
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


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
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