drugset / Trial / NCT01999725

Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788

NCT01999725 ↗

Phase 1 Completed 80 enrolled Enanta Pharmaceuticals, Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to determine the safety of single doses of orally administered EDP-788. Secondary objectives of the study are: * To describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after single doses of orally administered drug * To estimate the bioavailability of EDP-788 capsules relative to an oral liquid suspension * To estimate the effect of co-administration of food on the absorption of EDP-788

Timeline

Start
2014-01
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject EDP-788 Unknown — Oral

Indications

No indication recorded.