Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.
- Conditions
- COVID-19
- Interventions
- Registration Number
- NCT05594602
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
-
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description EDP-235 and Itraconazole interaction (Part 1) EDP-235 Subjects will receive EDP-235 and Itraconazole on respective dosing days EDP-235 and Carbamazepine interaction (Part 2) EDP-235 Subjects will receive EDP-235 and Carbamazepine on respective dosing days EDP-235 and Carbamazepine interaction (Part 2) Carbamazepine Subjects will receive EDP-235 and Carbamazepine on respective dosing days EDP and Quinidine interaction (Part 3) EDP-235 Subjects will receive EDP-235 and Quinidine on respective dosing days EDP-235 and Itraconazole interaction (Part 1) Itraconazole Subjects will receive EDP-235 and Itraconazole on respective dosing days EDP and Quinidine interaction (Part 3) Quinidine Subjects will receive EDP-235 and Quinidine on respective dosing days
- Primary Outcome Measures
Name Time Method Cmax of EDP-235 with and without coadministration with Carbamazepine Day 1 through Day 26 Cmax of EDP-235 with and without coadministration with Quinidine Day 1 through Day 13 Cmax of EDP-235 with and without coadministration with Itraconazole Day 1 through Day 19 AUC of EDP-235 with and without coadministration with Carbamazepine Day 1 through Day 26 AUC of EDP-235 with and without coadministration with Itraconazole Day 1 through Day 19 AUC of EDP-235 with and without coadministration with Quinidine Day 1 through Day 13
- Secondary Outcome Measures
Name Time Method Safety measured by adverse events Up to 34 days
Trial Locations
- Locations (1)
ICON, plc.
🇺🇸Lenexa, Kansas, United States