| Trial ID: | L0083 |
| Source ID: | NCT03681457
|
| Associated Drug: |
Tropifexor
|
| Title: |
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: LJN452
|
| Outcome Measures: |
Cmax|Tmax|AUClast|AUCinf|T1/2|CL/F|Vz/F|fu|Cmax,u|AUClast,u|AUCinf,u|CL/F,u
|
| Sponsor/Collaborators: |
Novartis Pharmaceuticals|Novartis
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
42
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
September 24, 2018
|
| Completion Date: |
September 25, 2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
December 14, 2020
|
| Locations: |
Novartis Investigative Site, Orlando, Florida, United States|Novartis Investigative Site, Orlando, Florida, United States|Novartis Investigative Site, Knoxville, Tennessee, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03681457
|
