Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease

Completed · Phase 1

Conditions studied: Hepatitis C

In brief

The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function

Key facts

Study ID

NCT01886599

Run by

Bristol-Myers Squibb

People needed

48

Starts

2012-11-01

Expected to finish

2013-02-01

Last updated by the study team

2013-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Group A: Subjects with normal renal function
• Group B: Patients with end stage renal disease
• Group C: Patients with mild renal impairment
• Group D: Patients with moderate renal impairment
• Group E: Patients with severe renal impairment

You may not qualify if…

• History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease
• Hepatitis B or C
• Human Immunodeficiency Virus (HIV)
• Recent gastrointestinal disease

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• Davita Clinical Research — Minneapolis, Minnesota, United States
• New Orleans Center For Clinical Research — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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