Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine 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 fluconazole or quinidine 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 Fluconazole and Quinidine 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: Fluconazole
* Drug: Quinidine
* Drug: EDP-305
* 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. Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior history of QT abnormality. For Part 2 subjects, the following cardiovascular abnormalities QRS duration >110 ms Incomplete right bundle branch block or any complete bundle branch block Heart rate <40 or >90 beats per minute (per vital sign capture while rested) History of unexplained syncope, structural heart disease, or clinically significant arrhythmias Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome PR interval >220 ms or any 2nd or 3rd degree AV block Ventricular pre-excitation

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: EDP-305 and fluconazole interaction (Part 1)<br> | Drug: Fluconazole<br>* Subjects will receive fluconazole once daily from Day 5 to Day 18<br>Drug: EDP-305<br>* Subjects will receive a single dose of EDP-305 on Day 1 and Day 14<br>|
| Experimental: EDP-305 and quinidine interaction (Part 2)<br> | Drug: Quinidine<br>* Subjects will receive quinidine twice daily from Day 5 to Day 12<br>Drug: EDP-305<br>* Subjects will receive a single dose of EDP-305 on Day 1 and Day 8<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 fluconazole |  | Up to 19 days | 
| AUC of EDP-305 with and without coadministration with fluconazole |  | Up to 19 days | 
| Cmax of EDP-305 with and without coadministration with quinidine |  | Up to 13 days | 
| AUC of EDP-305 with and without coadministration with quinidine |  | Up to 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by adverse events |  | Up to 25 days | 

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