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

A Phase I, Open Label, Non-randomized 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 With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Madrigal Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment
• NASH - Nonalcoholic Steatohepatitis
• Cirrhosis, Liver

Interventions

Type	Name	Description
DRUG	MGL-3196	Once daily oral dose for 6 days

Timeline

• Start date: 2018-10-25
• Primary completion: 2021-08-04
• Completion: 2021-08-04
• First posted: 2020-11-25
• Last updated: 2023-10-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study