Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

Study Overview
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Brief Summary
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A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

Official Title
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A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

Conditions
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RSV Infection

Intervention / Treatment
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* Drug: EDP-938
* Drug: EDP-938
* Drug: EDP-938
* Drug: Tacrolimus
* Drug: Dabigatran
* Drug: Rosuvastatin
* Drug: EDP-938
* Drug: Midazolam


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. For Part 1 subjects: Clinical history or evidence at Screening consistent with hyperkalemia, hypertension and/or diabetes mellitus For Part 2 Subjects: Clinical history or evidence at screening of medically significant bleeding History of a mechanical heart valve placement, a thromboembolic event or clinically significant thrombotic event, an autoimmune disease, eg, systemic lupus erythematosus (SLE), or recurrent spontaneous abortions A platelet count <LLN, or INR >ULN, or aPTT > ULN at Screening Ongoing daily use of nonsteroidal anti-inflammatory drugs For Part 3 subjects: AST and/or ALT >ULN at Screening For Part 4 subjects: History of glaucoma

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: 4-Part Single Group study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-938 and tacrolimus interaction (Part 1)<br> | Drug: EDP-938<br>* Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1)<br>Drug: Tacrolimus<br>* Subjects will receive tacrolimus once daily on Day 1 and Day 24<br>|
| Experimental: EDP-938 and dabigatran interaction (Part 2)<br> | Drug: EDP-938<br>* Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2)<br>Drug: Dabigatran<br>* Subjects will receive dabigatran once daily on Day 1 and Day 13<br>|
| Experimental: EDP-938 and rosuvastatin interaction (Part 3)<br> | Drug: EDP-938<br>* Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3)<br>Drug: Rosuvastatin<br>* Subjects will receive rosuvastatin once daily on Day 1 and Day 13<br>|
| Experimental: EDP-938 and midazolam interaction (Part 4)<br> | Drug: EDP-938<br>* Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)<br>Drug: Midazolam<br>* Subjects will receive midazolam once daily on Day 1 and Day 16<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of tacrolimus with and without coadministration with EDP-938 |  | up to 29 days | 
| AUC of tacrolimus with and without coadministration with EDP-938 |  | up to 29 days | 
| Cmax of dabigatran with and without coadministration with EDP-938 |  | up to 17 days | 
| AUC of dabigatran with and without coadministration with EDP-938 |  | up to 17 days | 
| Cmax of rosuvastatin with and without coadministration with EDP-938 |  | up to 17 days | 
| AUC of rosuvastatin with and without coadministration with EDP-938 |  | up to 17 days | 
| Cmax of midazolam with and without coadministration with EDP-938 |  | up to 17 days | 
| AUC of midazolam with and without coadministration with EDP-938 |  | up to 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by adverse events |  | up to 34 days | 

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