Hepatitis B
Conditions
Keywords
drug-drug interaction
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.
Interventions
DRUGEDP-514
Subjects will receive EDP-514 on Days 1 and 14
DRUGItraconazole
Subjects will receive itraconazole QD for 14 days
DRUGCarbamazepin
Subjects will receive carbamazepine BID for 23 days
DRUGQuinidine
Subjects will receive quinidine BID for 8 days
Sponsors
PRA Health Sciences
Enanta Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
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. * 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.
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 clinically significant active infection. * A positive urine drug screen at Screening or Day -1. * Current tobacco smokers or use of tobacco products within 3 months prior to Screening. * 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). * History of regular alcohol consumption * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of EDP-514 with and without coadministration with carbamazepine | up to 28 days |
| Cmax of EDP-514 with and without coadministration with itraconazole | up to 19 days |
| AUC of EDP-514 with and without coadministration with itraconazole | 19 days |
| AUC of EDP-514 with and without coadministration with quinidine | up to 13 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | up to 34 days |
Countries
United States
Outcome results
None listed