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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Safety in Normal Volunteers

Intervention / Treatment
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* Drug: EDP-788
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-788<br>Single doses with dose escalation to continue in successive cohorts | Drug: EDP-788<br>* EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses<br>|
| Placebo Comparator: Placebo<br>Single dose with matching placebo | Drug: Placebo<br>* Matching placebo capsules or matching suspension<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normal Volunteers, Safety, Pharmacokinetics