Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788

May 8, 2015 updated by: Enanta Pharmaceuticals, Inc

A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers

The primary objective of the study is to determine the safety and tolerability of multiple 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 multiple doses of orally administered drug.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Three cohorts of subjects will be enrolled to receive either EDP-788 or placebo. The dose of EDP-788 will be increased with each successive cohort. In addition, a 4th cohort may be enrolled, depending on clinical findings (tolerability, safety, pharmacokinetics) observed in the first 3 cohorts. In each cohort, 8 subjects will receive a q12h oral dose regimen of EDP-788 (6 subjects) or placebo (2 subjects). All subjects receive multiple doses of study drug (EDP-788 or placebo).

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Austin, Texas, United States, 78744
        • PPD Phase 1 Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • In good general health
  • BMI between 18 - 32 kg/m2
  • Women must be of non-childbearing potential (surgically sterilized)
  • Normal electrocardiogram
  • Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 17 - 19 day post-dosing visit

Key Exclusion Criteria:

  • Hypersensitivity to macrolide antibiotics
  • Abnormal laboratory values
  • Gastroenteritis within 1 week of study drug administration
  • Use of any investigational drugs within 28 days of study drug administration
  • History of gastrointestinal surgery which may interfere with drug absorption
  • Active Hepatitis B, Hepatitis C, or HIV infection
  • Use of prescription or non-prescription drugs within 14 days of study drug administration
  • Use of nicotine within 3 months of study drug administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDP-788
Multiple doses with dose escalation to continue in successive cohorts
EDP-788 Capsules. All interventions are given as multiple doses.
Placebo Comparator: Placebo
Multiple doses with dose escalation to continue in successive cohorts
Matching placebo capsules. All interventions are given as multiple doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events
Time Frame: From time of dosing to 20-23 days after receiving last dose of study drug
From time of dosing to 20-23 days after receiving last dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in laboratory values and vital signs
Time Frame: From time of dosing to 20-23 days after receiving last dose of study drug
From time of dosing to 20-23 days after receiving last dose of study drug
Pharmacokinetic parameters
Time Frame: From time of dosing to 3 days after receiving the last dose of study drug
As measured by peak plasma concentration (Cmax)
From time of dosing to 3 days after receiving the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 8, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • EDP788-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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