Overview
Two-way Interaction Between Alisporivir and EDP239
Status:
Completed
Completed
Trial end date:
2014-11-01
2014-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of Part 1 is to inform dose selection for use of alisporivir and EDP239 in combination and obtain initial safety data for co-administration of alisporivir and EDP239 to support future treatment studies in patients. The purpose of Part 2 is to inform the drug-drug interaction potential of EDP239 more broadly and possibly facilitate the interpretation of lower than expected alisporivir concentrations in Part 1, if observed.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Enanta Pharmaceuticals
Criteria
Inclusion Criteria:- Male or female subjects 18 to 55 years of age
- Body weight at least 50 kg
Exclusion Criteria:
- Women of child bearing potential
- Tobacco use
- History or evidence of any inherited bilirubin disease or disorder, including not not
necessarily limited to Dubin-Johnson Syndrome, Gilbert's syndrome, and Rotor Syndrome