| Trial ID: | L0310 |
| Source ID: | NCT03213145
|
| Associated Drug: |
EDP-305
|
| Title: |
Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: intraconazole|Drug: Rifampin|Drug: EDP 305
|
| Outcome Measures: |
Cmax of EDP-305 with and without coadministration with itraconazole|AUC of EDP-305 with and without coadministration with itraconazole|Cmax of EDP-305 with and without coadministration with rifampin|AUC of EDP-305 with and without coadministration with rifampin|Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
|
| Sponsor/Collaborators: |
Enanta Pharmaceuticals
|
| Gender: |
All
|
| Age: |
18 Years to 55 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
48
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
|
| Start Date: |
July 11, 2017
|
| Completion Date: |
September 7, 2017
|
| Results First Posted: |
--
|
| Last Update Posted: |
November 6, 2017
|
| Locations: |
Pharmaceutical Research Associates, Inc.,, Lenexa, Kansas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03213145
|
