Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects

Study Overview
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Brief Summary
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Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.

Official Title
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A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, and Quinidine on the Pharmacokinetics and Safety of EDP-514 in Healthy Subjects

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: EDP-514
* Drug: EDP-514
* Drug: EDP-514
* Drug: Itraconazole
* Drug: Carbamazepin
* 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. Male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive Female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-514. Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. 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 clinically significant active infection. A positive urine drug screen at Screening or Day -1. Current tobacco smokers or use of tobacco products within 3 months prior to Screening. Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). • Clinically significant laboratory abnormalities at screening or Day -1, as determined by the Investigator (including but not limited to hypokalemia, hypocalcemia, or hypomagnesemia for Part 3 participants). History of regular alcohol consumption Participation in a clinical trial within 30 days prior to the first dose of study drug. For Part 2 (Carbamazepine) participants: Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) with HLA-B 1502 in this population. Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-514 and Itraconazole interaction (Part 1)<br> | Drug: EDP-514<br>* Subjects will receive EDP-514 on Days 1 and 14<br>Drug: Itraconazole<br>* Subjects will receive itraconazole QD for 14 days<br>|
| Experimental: EDP-514 and Carbamazepine interaction (Part 2)<br> | Drug: EDP-514<br>* Subjects will receive EDP-514 on Days 1 and 23<br>Drug: Carbamazepin<br>* Subjects will receive carbamazepine BID for 23 days<br>|
| Experimental: EDP-514 and Quinidine interaction (Part 3)<br> | Drug: EDP-514<br>* Subjects will receive EDP-514 on Days 1 and 8<br>Drug: Quinidine<br>* Subjects will receive quinidine BID for 8 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of EDP-514 with and without coadministration with itraconazole |  | up to 19 days | 
| AUC of EDP-514 with and without coadministration with itraconazole |  | 19 days | 
| Cmax of EDP-514 with and without coadministration with carbamazepine |  | up to 28 days | 
| AUC of EDP-514 with and without coadministration with carbamazepine |  | up to 28 days | 
| Cmax of EDP-514 with and without coadministration with quinidine |  | up to 13 days | 
| AUC of EDP-514 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 34 days | 

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