Status:
COMPLETED
Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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
Detailed Description
Primary Purpose: Other: 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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01886599
Start Date
November 1 2012
End Date
February 1 2013
Last Update
November 11 2013
Active Locations (3)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
2
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404
3
New Orleans Center For Clinical Research
Knoxville, Tennessee, United States, 37920