| Trial ID: | L0339 |
| Source ID: | NCT00856869
|
| Associated Drug: |
NRL972
|
| Title: |
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Hepatic Cirrhosis|Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: NRL972
|
| Outcome Measures: |
Clearance of NRL972 after a standard meal and while fasted in healthy volunteers, patients with NASH and patients with hepatic cirrhosis.|Adverse events and changes in physical findings from baseline|Effects of vital signs: blood pressure, pulse rate|Effects on electrocardiogram|Changes in haematology, clinical chemistry, urinalysis
|
| Sponsor/Collaborators: |
Norgine
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1/Phase 2
|
| Enrollment: |
52
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Diagnostic
|
| Start Date: |
August 2004
|
| Completion Date: |
April 2005
|
| Results First Posted: |
--
|
| Last Update Posted: |
March 6, 2009
|
| Locations: |
UMHAPT St. Ivan Rilski's University Hospital, Sofia, Bulgaria
|
| URL: |
https://ClinicalTrials.gov/show/NCT00856869
|
