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NCT06397872

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

A Phase 1, Multi-center, Open-label 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
Madrigal Pharmaceuticals, Inc.·Phase 1·ClinicalTrials.gov·drugEnrolling by invitation
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Renal Impairment
Drug/Device/Intervention
100 mg Resmetirom Tablet
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Madrigal Pharmaceuticals, Inc.
Location
Orlando,Tampa,Chicago, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Mar 05, 2024
End date
Dec 31, 2024
Enrollment
28 participants
Primary outcome

Plasma pharmacokinetics - Cmax,Plasma pharmacokinetics - Tmax,Plasma pharmacokinetics - AUC(0-Last),Plasma pharmacokinetics - t1/2

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.

ICD-10 classifications
Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06397872
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06397872 through Pure Global AI's free database. This Phase 1 trial is sponsored by Madrigal Pharmaceuticals, Inc. and is currently Enrolling by invitation. The study focuses on Renal Impairment. Target enrollment is 28 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.