Drug Drug Interaction (DDI), RSV Infection
Conditions
Keywords
Drug Drug Interaction
Brief summary
The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.
Interventions
DRUGEDP-323
Subjects will receive EDP-323 on Days 1 and 14
DRUGItraconazole
Subjects will receive itraconazole QD Days 5-18
DRUGcarbamazepine
Subjects will receive carbamazepine on Days 5 - 27
DRUGQuinidine
Subjects will receive quinidine on Days 5-12
DRUGfluconazole
Subjects will receive fluconazole on Days 5-18
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 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 65 years, inclusive. * Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of50 kg * Female subjects 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-323. 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 exceeding protocol limits * Participation in a clinical trial within 28 days prior to the first dose of study drug * 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 * Other exclusions for Part 2 (carbamazepine) participants * Participants of Asian ancestry with HLA allele 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 |
|---|---|
| AUC of EDP-323 with and without coadministration with fluconazole | Day 1 through Day 19 |
| Cmax of EDP-323 with and without coadministration with Itraconazole | Day 1 through Day 19 |
| AUC of EDP-323 with and without coadministration with Itraconazole | Day 1 through Day 19 |
| Cmax of EDP-323 with and without coadministration with Carbamazepine | Day 1 through Day 28 |
| AUC of EDP-323 with and without coadministration with Carbamazepine | Day 1 through Day 28 |
| Cmax of EDP-323 with and without coadministration with Quinidine | Day 1 through Day 13 |
| AUC of EDP-323 with and without coadministration with Quinidine | Day 1 through Day 13 |
| Cmax of EDP-323 with and without coadministration with fluconazole | Day 1 through Day 19 |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 34 Days |
Countries
United States
Outcome results
None listed