Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects
NCT05594615 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2023-04-27
Summary
A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.
Conditions
Interventions
- DRUG
-
EDP-235
Subjects will receive EDP-235 once daily on Days 5-15
- DRUG
-
Midazolam
Subjects will receive midazolam once daily on Days 1 and 12
- DRUG
-
Rosuvastatin
Subjects will receive rosuvastatin once daily on Days 2 and 13
- DRUG
-
Caffeine
Subjects will receive caffeine once daily on Days 1 and 12
Sponsors & Collaborators
-
Enanta Pharmaceuticals, Inc
lead INDUSTRY
Principal Investigators
-
Enanta Pharmaceuticals, Inc · Enanta Pharmaceuticals, Inc
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-06
- Primary Completion
- 2022-11-04
- Completion
- 2022-11-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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