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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 - Trial NCT06397872

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.

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NCT06397872
Phase 1
Enrolling by invitation
drug
Trial Details
ClinicalTrials.gov • NCT06397872
View on ClinicalTrials.gov
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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

Study Focus

Renal Impairment

100 mg Resmetirom Tablet

Interventional

drug

Sponsor & Location

Madrigal Pharmaceuticals, Inc.

Orlando,Tampa,Chicago, United States of America

Timeline & Enrollment

Phase 1

Mar 05, 2024

Dec 31, 2024

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 failure
Disorders resulting from impaired renal tubular function
Disorder resulting from impaired renal tubular function, unspecified
Other disorders resulting from impaired renal tubular function
Acute renal failure

Data Source

ClinicalTrials.gov

NCT06397872

Non-Device Trial