COVID-19
Conditions
Keywords
drug-drug interaction
Brief summary
A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.
Interventions
DRUGEDP-235
Subjects will receive EDP-235 once daily on Days 5-15
DRUGMidazolam
Subjects will receive midazolam once daily on Days 1 and 12
DRUGRosuvastatin
Subjects will receive rosuvastatin once daily on Days 2 and 13
DRUGCaffeine
Subjects will receive caffeine once daily on Days 1 and 12
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
* 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 * History of drug allergy to midazolam, caffeine, or rosuvastatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 | Up to 17 Days |
| AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 | Up to 17 Days |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 22 days |
Countries
United States
Outcome results
None listed