COVID-19
Conditions
Keywords
drug-drug interaction
Brief summary
A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.
Interventions
DRUGEDP-235
Subjects will receive EDP-235 on Days 1 and 14
DRUGItraconazole
Subjects will receive itraconazole QD Days 5-18
DRUGCarbamazepine
Subjects will receive carbamazepine BID Days 5-23 and Days 24-27
DRUGQuinidine
Subjects will receive quinidine BID Days 5-12
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of EDP-235 with and without coadministration with Carbamazepine | Day 1 through Day 26 |
| Cmax of EDP-235 with and without coadministration with Itraconazole | Day 1 through Day 19 |
| 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 |
| AUC 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 34 days |
Countries
United States
Outcome results
None listed