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

Status:	Completed
Conditions:	Infectious Disease, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	11/18/2012
Start Date:	September 2012
End Date:	January 2013
Contact:	For participation information at a USA site use a phone number below. For Site information outside USA please email:
Email:	Clinical.Trials@bms.com

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

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

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

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

We found this trial at

sites

Clinical Pharmacology of Miami

Miami, Florida 33014

from

Miami, FL