A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants
Completed · Phase 1
Conditions studied: RSV Infection, Drug Drug Interaction
In brief
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.
Key facts
- Study ID
- NCT06917508
- Run by
- Enanta Pharmaceuticals, Inc
- People needed
- 24
- Starts
- 2025-03-13
- Expected to finish
- 2025-06-13
- Last updated by the study team
- 2025-07-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- ICON, plc — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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