| Trial ID: | L0528 |
| Source ID: | NCT03207425
|
| Associated Drug: |
EDP-305
|
| Title: |
A Phase 1, Open-Label, Parallel Group, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of EDP 305 in Subjects With Varying Degrees of Hepatic Function
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH;NASH;NASH;NASH
|
| Interventions: |
Drug: EDP 305;Drug: EDP 305;Drug: EDP 305;Drug: EDP 305
|
| Outcome Measures: |
Cmax of EDP 305;AUCinf of EDP 305;t1/2 of EDP 305;CL/F of EDP 305;Cmax of EDP 305;AUCinf of EDP 305;t1/2 of EDP 305;CL/F of EDP 305;Cmax of EDP 305;AUCinf of EDP 305;t1/2 of EDP 305;CL/F of EDP 305Safety 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 Years75 Years
|
| Phases: |
Phase 1
|
| Enrollment: |
29
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
|
| Start Date: |
30/06/2017
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
16 December 2017
|
| Locations: |
United States;Czechia;Slovakia;Czechia;Slovakia;United States;United States;Czechia;Slovakia;Czechia;Slovakia;United States;United States;Czechia;Slovakia;Czechia;Slovakia;United States;United States;Czechia;Slovakia;Czechia;Slovakia;United States;United States;Czechia;Slovakia;Czechia;Slovakia;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03207425
|
