Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses 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 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.

Detailed Description
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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).

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

Conditions
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Healthy

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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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>Multiple doses with dose escalation to continue in successive cohorts | Drug: EDP-788<br>* EDP-788 Capsules. All interventions are given as multiple doses.<br>|
| Placebo Comparator: Placebo<br>Multiple doses with dose escalation to continue in successive cohorts | Drug: Placebo<br>* Matching placebo capsules. All interventions are given as multiple doses<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 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 |  | From time of dosing to 20-23 days after receiving last dose of study drug | 
| Pharmacokinetic parameters | As measured by peak plasma concentration (Cmax) | From time of dosing to 3 days after receiving the last dose of 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