Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT05594602
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05594602
Study Brief:
Protocol Section:
NCT05594602