Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.
Purpose
A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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 - For Part 2 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. - For Part 2 and Part 3 participants, 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 - History of drug allergy to itraconazole or other azole antifungals; history of drug allergy to carbamazepine or carboxamide derivatives [e.g. oxcarbazepine]; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);history or known hypersensitivity to mefloquine, quinine, or quinidine
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental EDP-235 and Itraconazole interaction (Part 1) |
Subjects will receive EDP-235 and Itraconazole on respective dosing days |
|
|
Experimental EDP-235 and Carbamazepine interaction (Part 2) |
Subjects will receive EDP-235 and Carbamazepine on respective dosing days |
|
|
Experimental EDP and Quinidine interaction (Part 3) |
Subjects will receive EDP-235 and Quinidine on respective dosing days |
|
Recruiting Locations
More Details
- NCT ID
- NCT05594602
- Status
- Completed
- Sponsor
- Enanta Pharmaceuticals, Inc