Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects

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

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

Conditions
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RSV Infection

Intervention / Treatment
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* Drug: EDP-938
* Drug: EDP-938
* Drug: Cyclosporine
* Drug: Prednisone


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. 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.

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-938 and cyclosporine interaction (Part 1)<br> | Drug: EDP-938<br>* Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)<br>Drug: Cyclosporine<br>* Subjects will receive one dose of cyclosporine on Day 5<br>|
| Experimental: EDP-938 and prednisone interaction (Part 2)<br> | Drug: EDP-938<br>* Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2)<br>Drug: Prednisone<br>* Subjects will receive prednisone once daily from Day 5 to Day 14<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 cyclosporine |  | Up to 12 days | 
| AUC of EDP-938 with and without coadministration with cyclosporine |  | Up to 12 days | 
| Cmax of EDP-938 with and without coadministration with prednisone |  | Up to 21 days | 
| AUC of EDP-938 with and without coadministration with prednisone |  | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by adverse events |  | Up to 21 days | 

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