| Trial ID: | L0016 |
| Source ID: | NCT01999101
|
| Associated Drug: |
Px-104
|
| Title: |
Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non Alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Px-104
|
| Outcome Measures: |
Safety|Change of hepatocellular lipid content|Changes in oral glucose tolerance test (oGTT)|Change from baseline in fibroblast growth factor 19 (FGF-19)|Change from baseline in plasma bile acid concentration|Pharmacokinetics of Px-104 and conjugates
|
| Sponsor/Collaborators: |
Phenex Pharmaceuticals AG|Medical University of Vienna
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
12
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
October 2013
|
| Completion Date: |
June 2016
|
| Results First Posted: |
--
|
| Last Update Posted: |
September 29, 2016
|
| Locations: |
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Vienna, Austria
|
| URL: |
https://ClinicalTrials.gov/show/NCT01999101
|
