| Trial ID: | L0306 |
| Source ID: | NCT03783897
|
| Associated Drug: |
EDP-305
|
| Title: |
A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: EDP-305|Drug: Oral Contraceptive
|
| Outcome Measures: |
Area under the plasma concentration-time (AUC0-??) curve for OC with and without coadministration with EDP-305|Cmax for OC with and without coadministration with EDP-305|Area under the plasma concentration-time (AUC0-??) curve for EDP-305 when coadministration with OC|Cmax for EDP-305 when coadministration with OC|Safety measured by adverse events
|
| Sponsor/Collaborators: |
Enanta Pharmaceuticals|Covance
|
| Gender: |
Female
|
| Age: |
18 Years to 45 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
43
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
|
| Start Date: |
November 27, 2018
|
| Completion Date: |
June 18, 2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
July 24, 2019
|
| Locations: |
Covance Clinical Research Unit, Madison, Wisconsin, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03783897
|
