Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects

Study Overview
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Brief Summary
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A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.

Official Title
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A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS

Conditions
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COVID-19

Intervention / Treatment
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* Drug: EDP-235
* Drug: Midazolam
* Drug: Rosuvastatin
* Drug: Caffeine


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-235. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug. 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 History of drug allergy to midazolam, caffeine, or rosuvastatin

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-235, midazolam, rosuvastatin and caffeine<br>Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days | Drug: EDP-235<br>* Subjects will receive EDP-235 once daily on Days 5-15<br>Drug: Midazolam<br>* Subjects will receive midazolam once daily on Days 1 and 12<br>Drug: Rosuvastatin<br>* Subjects will receive rosuvastatin once daily on Days 2 and 13<br>Drug: Caffeine<br>* Subjects will receive caffeine once daily on Days 1 and 12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 |  | Up to 17 Days | 
| AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 |  | Up to 17 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by adverse events |  | Up to 22 days | 

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