Status:
COMPLETED
A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Conditions:
RSV Infection
Drug Drug Interaction
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06917508
Start Date
March 13 2025
End Date
June 13 2025
Last Update
July 1 2025
Active Locations (1)
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1
ICON, plc
San Antonio, Texas, United States, 78209