Clinical Trials Directory

Trials / Completed

CompletedNCT02173574

Two-way Interaction Between Alisporivir and EDP239

An Open-label, Two Part Investigation of the Pharmacokinetics, Safety, and Tolerability of Alisporivir and EDP239 When Co-administered to Healthy Adult Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Enanta Pharmaceuticals, Inc · Industry
Sex
All
Age
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDEB025
DRUGEDP239

Timeline

Start date
2014-08-01
Primary completion
2014-11-01
Completion
2014-11-01
First posted
2014-06-25
Last updated
2015-01-09

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02173574. Inclusion in this directory is not an endorsement.