A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function

Phase 1 Completed 28 enrolled Madrigal Pharmaceuticals, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of resmetirom and its major metabolite (MGL-3623) following oral administration of 100 mg resmetirom (QD x 6 days) in subjects with severe renal impairment (RI) compared to healthy matched control subjects with normal renal function.

Timeline

Start: 2024-03-06
Primary completion: 2024-09-16
Completion: 2024-12-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Resmetirom	Small molecule	100 mg	Oral

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function

Summary

Timeline

Drugs

Indications