Trials / Completed
CompletedNCT05594602
Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.
A NON-RANDOMIZED, OPEN-LABEL, THREE-PART, DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECTS OF ITRACONAZOLE, CARBAMAZEPINE, AND QUINIDINE ON THE PHARMACOKINETICS AND SAFETY OF EDP-235 IN HEALTHY PARTICIPANTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (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 itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EDP-235 | Subjects will receive EDP-235 on Days 1 and 14 |
| DRUG | EDP-235 | Subjects will receive EDP-235 on Days 1 and 23 |
| DRUG | EDP-235 | Subjects will receive EDP-235 on Days 1 and 8 |
| DRUG | Itraconazole | Subjects will receive itraconazole QD Days 5-18 |
| DRUG | Carbamazepine | Subjects will receive carbamazepine BID Days 5-23 and Days 24-27 |
| DRUG | Quinidine | Subjects will receive quinidine BID Days 5-12 |
Timeline
- Start date
- 2022-10-06
- Primary completion
- 2022-12-14
- Completion
- 2022-12-30
- 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 NCT05594602. Inclusion in this directory is not an endorsement.