Status:
COMPLETED
Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects
Lead Sponsor:
Debiopharm International SA
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 heal...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female, 18 to 70 years of age, in good health
- Stable Child-Turcotte-Pugh score of at least 5
- Body weight of at least 50 kg and a BMI of 18.0 to 36.0 kg/m2
- Exclusion criteria:
- Use of other investigational drugs
- Women of child-bearing potential
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01860326
Start Date
March 1 2011
End Date
September 1 2011
Last Update
April 28 2016
Active Locations (2)
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1
University of Miami
Miami, Florida, United States, 33136
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809