RSV Infection
Conditions
Keywords
drug-drug interaction
Brief summary
A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Interventions
DRUGEDP-938
Subjects will receive EDP-938 once daily on Days 1 and 14
DRUGFluconazole
Subjects will receive fluconazole once daily on Days 5 to 18
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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 938.
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. * Clinically significant history of drug sensitivity or allergy to fluconazole or other azole antifungals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of EDP-938 with and without coadministration with fluconazole | Up to 19 days |
| AUC of EDP-938 with and without coadministration with fluconazole | Up to 19 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 25 Days |
Countries
United States
Outcome results
None listed