Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects
- Registration Number
- NCT01860326
- Lead Sponsor
- Debiopharm International SA
- Brief Summary
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal liver function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Alisporivir Alisporivir Single 200 mg oral dose
- Primary Outcome Measures
Name Time Method Maximum Concentration (Cmax) of alisporivir 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose Area under the time-concentration curve (AUC) for alisporivir 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose Categories: AUC up to the last measurable concentration (AUClast) and AUC from time 0 to the last time point measured (AUC0-t)
- Secondary Outcome Measures
Name Time Method Apparent total body clearance from plasma (CL/F) of alisporivir 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose Apparent volume of distribution (Vz/F) of alisporivir 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose Time to maximum concentration (Tmax) of alisporivir 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose Half-Life (T1/2) of alisporivir 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose
Trial Locations
- Locations (2)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States