Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

Study Overview
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Brief Summary
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This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

Official Title
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A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers

Conditions
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NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: intraconazole
* Drug: Rifampin
* Drug: EDP 305


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An informed consent document signed and dated by the subject. Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. Female subjects must be of non-childbearing potential. Exclusion Criteria: Clinically relevant evidence or history of illness or disease. Pregnant or nursing females. History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. A positive urine drug screen at screening or Day -1. Current tobacco smokers or use of tobacco within 3 months prior to screening. Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). History of regular alcohol consumption. Participation in a clinical trial within 30 days prior to the first dose of study drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 2-Part Single Group study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br> | Drug: intraconazole<br>* Subjects will receive itraconazole once daily from Day 5 through Day18<br>Drug: EDP 305<br>* Subjects will receive EDP 305 once daily on Day 1 and Day 14<br>|
| Experimental: Part 2<br> | Drug: Rifampin<br>* Subjects will receive rifampin once daily from Day 5 through Day 16<br>Drug: EDP 305<br>* Subjects will receive EDP 305 once daily on Day 1 and Day 14<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of EDP-305 with and without coadministration with itraconazole |  | Up to 19 days | 
| AUC of EDP-305 with and without coadministration with itraconazole |  | Up to 19 days | 
| Cmax of EDP-305 with and without coadministration with rifampin |  | Up to 17 days | 
| AUC of EDP-305 with and without coadministration with rifampin |  | Up to 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). |  | Up to 19 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-drug interaction