Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects
- Conditions
- Hepatitis B
- Interventions
- Registration Number
- NCT04783753
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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.
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Clinically relevant evidence or history of illness or disease
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Pregnant or nursing females.
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History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of clinically significant active infection.
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A positive urine drug screen at Screening or Day -1.
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Current tobacco smokers or use of tobacco products within 3 months prior to Screening.
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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).
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History of regular alcohol consumption
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EDP-514 and Quinidine interaction (Part 3) Quinidine - EDP-514 and Carbamazepine interaction (Part 2) EDP-514 - EDP-514 and Carbamazepine interaction (Part 2) Carbamazepin - EDP-514 and Quinidine interaction (Part 3) EDP-514 - EDP-514 and Itraconazole interaction (Part 1) EDP-514 - EDP-514 and Itraconazole interaction (Part 1) Itraconazole -
- Primary Outcome Measures
Name Time Method Cmax of EDP-514 with and without coadministration with itraconazole up to 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 AUC of EDP-514 with and without coadministration with itraconazole 19 days
- Secondary Outcome Measures
Name Time Method Safety measured by adverse events up to 34 days
Trial Locations
- Locations (1)
Pharmaceutical Research Association
🇺🇸Lenexa, Kansas, United States