Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine 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 Itraconazole, Rifampin, and Quinidine 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 Itraconazole, Rifampin, and Quinidine 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: EDP-938
* Drug: EDP-938
* Drug: Itraconazole
* Drug: Rifampin
* Drug: Quinidine


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. For Part 3 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 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: 3-Part Single Group study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-938 and itraconazole interaction (Part 1)<br> | Drug: EDP-938<br>* Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1)<br>Drug: Itraconazole<br>* Subjects will receive itraconazole once daily from Day 5 to Day 18<br>|
| Experimental: EDP-938 and rifampin interaction (Part 2)<br> | Drug: EDP-938<br>* Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2)<br>Drug: Rifampin<br>* Subjects will receive rifampin once daily from Day 5 to Day 16<br>|
| Experimental: EDP-938 and quinidine interaction (Part 3)<br> | Drug: EDP-938<br>* Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3)<br>Drug: Quinidine<br>* Subjects will receive quinidine once daily from Day 5 to Day 12<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 itraconazole |  | Up to 19 days | 
| AUC of EDP-938 with and without coadministration with itraconazole |  | Up to 19 days | 
| Cmax of EDP-938 with and without coadministration with rifampin |  | Up to 17 days | 
| AUC of EDP-938 with and without coadministration with rifampin |  | Up to 17 days | 
| Cmax of EDP-938 with and without coadministration with quinidine |  | Up to 13 days | 
| AUC of EDP-938 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