| Trial ID: | L0354 |
| Source ID: | NCT04643795
|
| Associated Drug: |
MGL-3196
|
| Title: |
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Hepatic Impairment|NASH - Nonalcoholic Steatohepatitis|Cirrhosis, Liver
|
| Interventions: |
Drug: MGL-3196
|
| Outcome Measures: |
Plasma pharmacokinetics - Cmax|Plasma pharmacokinetics - Tmax|Plasma pharmacokinetics - AUC (0-last)|Plasma pharmacokinetics - t1/2|Effect on the incidence of adverse events
|
| Sponsor/Collaborators: |
Madrigal Pharmaceuticals, Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 85 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
90
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
October 24, 2018
|
| Completion Date: |
March 31, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
December 3, 2020
|
| Locations: |
Madrigal Research Center, Orlando, Florida, United States|Madrigal Research Center, Saint Paul, Minnesota, United States|Madrigal Research Center, San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT04643795
|
