Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788
Public ClinicalTrials.gov record NCT01999725. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Ascending One-Day (Single and Divided Dose) Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01999725
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2013
- Primary completion
- Aug 31, 2014
- Completion
- Aug 31, 2014
- Last update posted
- Jan 8, 2015
2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78744 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01999725, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 8, 2015 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01999725 live on ClinicalTrials.gov.