Trials / Completed
CompletedNCT05594615
Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects
A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Enanta Pharmaceuticals, Inc · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-10-06
- Primary completion
- 2022-11-04
- Completion
- 2022-11-18
- First posted
- 2022-10-26
- Last updated
- 2023-04-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05594615. Inclusion in this directory is not an endorsement.