| Trial ID: | L0052 |
| Source ID: | NCT00794716
|
| Associated Drug: |
NRL972
|
| Title: |
Pharmacokinetics of NRL972 in Patients With Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: NRL972
|
| Outcome Measures: |
The primary efficacy variable is the NRL972 fractional retention ratio for 10 and 30 minutes post-dose (C30/C10) for different populations with NAFLD.|Approximate overall clearance and t?? within 60 minutes of dosing with NRL972. Cmax, AUC(0-???), and mean residence time derived from a non-compartmental analysis.
|
| Sponsor/Collaborators: |
Norgine
|
| Gender: |
All
|
| Age: |
18 Years to 80 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
125
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Diagnostic
|
| Start Date: |
June 2008
|
| Completion Date: |
November 2011
|
| Results First Posted: |
--
|
| Last Update Posted: |
June 10, 2015
|
| Locations: |
Duke University Medical Center, Durham, North Carolina, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT00794716
|
