Drug Drug Interaction, RSV Infection
Conditions
Keywords
Drug Drug Interaction
Brief summary
The primary aim of this study is to assess the effect of EDP-323 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy adult participants.
Interventions
DRUGEDP-323
Subjects will receive EDP-323 once daily on Days 5-15
DRUGMidazolam
Subjects will receive midazolam once daily on Days 1 and 12
DRUGCaffeine
Subjects will receive caffeine once daily on Days 1 and 12
DRUGRosuvastatin
Subjects will receive rosuvastatin once daily on Days 2 and 13
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 weight \>50 kg and body mass index (BMI) of 18 to 32 kg/m2 * 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 * Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy) * Positive for HIV or hepatitis * Positive urine drug screen * Current tobacco smokers or use of tobacco within 3 months prior to Screening. * Received any vaccine, an investigational agent, or biological product within 28 days or 5 times the t½ of receipt of study drug, whichever is longer. * Drug sensitivity to midazolam, caffeine, rosuvastatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323 | Up to 17 Days |
| AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323 | Up to 17 Days |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 22 days |
Countries
United States
Outcome results
None listed