Clinical TrialID 3727
Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects
NCT04783753
Hepatitis B
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 3727
- Evidence Id
- 3727
- Core Evidence Id
- 3727
- Source Clinical Trial Id
- 3700
- Herb2 Clinical Trial Id
- HBCT003700
- Nct Id
- NCT04783753
- Title
- Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Hepatitis B
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
- Intervention
- DRUG: EDP-514|DRUG: EDP-514|DRUG: EDP-514|DRUG: Itraconazole|DRUG: Carbamazepin|DRUG: Quinidine
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Basic_Science
- Gender
- All
- Age
- Adult
- Enrollment
- 72
- Outcome Measure
- Cmax of EDP-514 with and without coadministration with itraconazole, up to 19 days|AUC of EDP-514 with and without coadministration with itraconazole, 19 days|Cmax of EDP-514 with and without coadministration with carbamazepine, up to 28 days|AUC of EDP-514 with and without coadministration with carbamazepine, up to 28 days|Cmax of EDP-514 with and without coadministration with quinidine, up to 13 days|AUC of EDP-514 with and without coadministration with quinidine, up to 13 days
- Sponsor Collaborator
- Enanta Pharmaceuticals, Inc|PRA Health Sciences
- Funded By
- INDUSTRY
- Location
- Pharmaceutical Research Association, Lenexa, Kansas, 66219, United States
- Other Id
- EDP 514-003
- Start Date
- 2020-11-05
- Primary Completion Date
- 2021-06-28
- Completion Date
- 2021-07-09
- First Posted
- 2021-03-05
- Results First Posted
- Last Update Posted
- 2021-08-16
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04783753
- Title Cn
- Title En
- Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects
- Bilingual Status
- semi_complete