Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects

Study Overview
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Brief Summary
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A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

Official Title
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A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

Conditions
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RSV Infection

Intervention / Treatment
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* Drug: EDP-938
* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938. 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 history of drug sensitivity or allergy to fluconazole or other azole antifungals

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-938 and Fluconazole interaction<br> | Drug: EDP-938<br>* Subjects will receive EDP-938 once daily on Days 1 and 14<br>Drug: Fluconazole<br>* Subjects will receive fluconazole once daily on Days 5 to 18<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of EDP-938 with and without coadministration with fluconazole |  | Up to 19 days | 
| AUC of EDP-938 with and without coadministration with fluconazole |  | Up to 19 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