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

Completed · Phase 1

Conditions studied: Chronic Hepatitis B Virus Infection, Chronic Hepatitis C Virus Infection

In brief

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

Key facts

Study ID

NCT01708889

Run by

Bristol-Myers Squibb

People needed

43

Starts

2012-09-01

Expected to finish

2013-02-01

Last updated by the study team

2013-06-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal renal function or mild, moderate, severe or end-stage renal dysfunction

You may not qualify if…

• 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

Where it is running

• Clinical Pharmacology Of Miami Inc. — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• New Orleans Center For Clinical Research - Knoxville — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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