RSV Infection
Conditions
Keywords
drug-drug interaction
Brief summary
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Interventions
DRUGEDP-938
Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1)
DRUGItraconazole
Subjects will receive itraconazole once daily from Day 5 to Day 18
DRUGRifampin
Subjects will receive rifampin once daily from Day 5 to Day 16
DRUGQuinidine
Subjects will receive quinidine once daily from Day 5 to Day 12
Sponsors
Pharmaceutical Research Associates
Enanta Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
3-Part Single Group study
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 938.
Exclusion criteria
* Clinically relevant evidence or history of illness or disease. * For Part 3 subjects, 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 * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of EDP-938 with and without coadministration with rifampin | Up to 17 days |
| Cmax of EDP-938 with and without coadministration with itraconazole | Up to 19 days |
| AUC of EDP-938 with and without coadministration with itraconazole | Up to 19 days |
| AUC of EDP-938 with and without coadministration with quinidine | Up to 13 days |
| AUC of EDP-938 with and without coadministration with rifampin | Up to 17 days |
| Cmax of EDP-938 with and without coadministration with quinidine | Up to 13 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 25 days |
Countries
United States
Outcome results
None listed