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

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

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 Overview

• Status: Completed
• Conditions: Safety in Normal Volunteers
• Intervention / Treatment: Drug: EDP-788; Drug: Placebo

Detailed Description

Subjects are enrolled in successive cohorts and are randomized to receive either EDP-788 or placebo capsules. If the safety profile of the drug is acceptable, based upon review of blinded data, the cohort receiving the next higher dose will be treated. Up to 8 cohorts will be recruited. All subjects receive a single dose of study drug (EDP-788 or placebo).

Subjects in Cohort C will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first dose. The second dose will be administered as a liquid suspension rather than as a capsule formulation. The purpose of the second dose is to estimate the bioavailability of the capsule formulation relative to the suspension.

Subjects in Cohort E will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first does. The second dose will be administered with a standard test meal. The purpose of the second dose is to estimate the effect of food on absorption of EDP-788.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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 8 - 10 day post-dosing visit

Key Exclusion Criteria:

• Hypersensitivity to macrolide antibiotics
• Abnormal laboratory values
• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EDP-788; Single doses with dose escalation to continue in successive cohorts	Drug: EDP-788; EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses
PLACEBO_COMPARATOR: Placebo; Single dose with matching placebo	Drug: Placebo; Matching placebo capsules or matching suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events	From time of dosing to 8 - 10 days after receiving study drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in laboratory values and vital signs	From time of dosing to 8 - 10 days after receiving study drug

Other Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters	From time of dosing to 3 days after receiving study drug

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc
• Investigators: Principal Investigator: Theresa T Pham, MD, PPD Phase I Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (ESTIMATE): December 3, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 7, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Normal Volunteers, Safety, Pharmacokinetics
• Other Study ID Numbers: EDP788-001