Status:
COMPLETED
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.
Detailed Description
Treatment, Parallel Assignment, Open Label, Non-Randomized, Single Dose Adaptive Design, Pharmacokinetics Study
Eligibility Criteria
Inclusion
- \- Meet renal function criteria in one of four categories
Exclusion
- \- Unstable or uncontrolled medical conditions
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01830205
Start Date
September 1 2012
End Date
June 1 2013
Last Update
November 16 2015
Active Locations (2)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
2
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404