Clinical TrialID 3724
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
NCT03610945
NASH - Nonalcoholic Steatohepatitis
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 3724
- Evidence Id
- 3724
- Core Evidence Id
- 3724
- Source Clinical Trial Id
- 3697
- Herb2 Clinical Trial Id
- HBCT003697
- Nct Id
- NCT03610945
- Title
- Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- NASH - Nonalcoholic Steatohepatitis
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
- Intervention
- DRUG: Fluconazole|DRUG: Quinidine|DRUG: EDP-305|DRUG: EDP-305
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Basic_Science
- Gender
- All
- Age
- Adult
- Enrollment
- 48
- Outcome Measure
- Cmax of EDP-305 with and without coadministration with fluconazole, Up to 19 days|AUC of EDP-305 with and without coadministration with fluconazole, Up to 19 days|Cmax of EDP-305 with and without coadministration with quinidine, Up to 13 days|AUC of EDP-305 with and without coadministration with quinidine, Up to 13 days
- Sponsor Collaborator
- Enanta Pharmaceuticals, Inc
- Funded By
- INDUSTRY
- Location
- Pharmaceutical Research Associates, Inc.,, Salt Lake City, Utah, 84124, United States
- Other Id
- EDP 305-007
- Start Date
- 2018-07-19
- Primary Completion Date
- 2018-08-15
- Completion Date
- 2018-08-21
- First Posted
- 2018-08-01
- Results First Posted
- Last Update Posted
- 2018-12-05
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT03610945
- Title Cn
- Title En
- Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
- Bilingual Status
- semi_complete