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

NCT01999725 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-01-09

No results posted yet for this study

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

Conditions

  • Safety in Normal Volunteers

Interventions

DRUG

EDP-788

EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses

DRUG

Placebo

Matching placebo capsules or matching suspension

Sponsors & Collaborators

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Theresa T Pham, MD · PPD Phase I Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01999725 on ClinicalTrials.gov