drugset / Trial / NCT04643795
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
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function, including a subset of NASH subjects.
Timeline
- Start
- 2018-10-25
- Primary completion
- 2021-08-04
- Completion
- 2021-08-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Resmetirom | Small molecule | 40 mg | Oral |
| Subject | Resmetirom | Small molecule | 60 mg | Oral |
| Subject | Resmetirom | Small molecule | 80 mg | Oral |
| Subject | Resmetirom | Small molecule | 100 mg | Oral |