Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects
Completed · Phase 1
Conditions studied: COVID-19
In brief
A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.
Key facts
- Study ID
- NCT05594615
- Run by
- Enanta Pharmaceuticals, Inc
- People needed
- 24
- Starts
- 2022-10-06
- Expected to finish
- 2022-11-18
- Last updated by the study team
- 2023-04-27
Who can join
Age: 18 and older, up to 55. 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 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.
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
- 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
Where it is running
- ICON, plc. — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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