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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04643795•Madrigal Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Capable of understanding and willing and able to sign written informed consent
•Male or female, between 18 and 85 years of age (inclusive)
•BMI between 18 and 45 kg/m2 (inclusive)
•In healthy subjects with normal hepatic function:
•* Considered by the Investigator to be healthy, based on medical and surgical history, physical examination including vital signs, 12-lead ECG, and laboratory test results
•* Match demographically with a subject in the hepatically impaired population according to gender, BMI (±20%), and age (±10 years)
•In subjects with hepatic impairment:
•* Considered by the Investigator to be clinically stable with respect to underlying HI, based on medical and surgical history, physical examination including vital signs, 12-lead ECG, and laboratory test results
•In subjects with NASH:
•* Confirmed diagnosis of NASH suggested by historical data, which include a previous liver biopsy within the last 5 years prior to randomization with evidence of NASH.
+1 more criteria

Exclusion Criteria

•Any clinically significant concomitant disease or condition (including treatment for such conditions) that, in the opinion of the Investigator, could either interfere with the study drug, pose an unacceptable risk to the subject, or compromise interpretation of study data
•Gilbert's syndrome
•Pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of study drug
•eGFR \<60 mL/min/1.73 m2 based on Modification of Diet in Renal Disease (MDRD) equation
•Received an investigational drug or device from another study within 30 days (or 5 half-lives, whichever is longer) prior to study drug administration
•In healthy subjects with normal hepatic function:
•* Systolic blood pressure outside the range of 90 to 150 mmHg, diastolic blood pressure outside the range of 40 to 95 mmHg or heart rate outside the range of 40 to 100 beats per minute (bpm)
•* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months prior to screening
•In subjects with hepatic impairment:
•* Any non-hepatic acute or chronic condition (including, but not limited to, poorly controlled diabetes and encephalopathy Grade ≥3) that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study
+2 more criteria

Locations (3)

Madrigal Research Center

Orlando, Florida, United States

Madrigal Research Center

Saint Paul, Minnesota, United States

Madrigal Research Center

San Antonio, Texas, United States

Key Dates

Start Date

October 25, 2018

Primary Completion Date

August 4, 2021

Completion Date

August 4, 2021

Last Updated

October 5, 2023

Enrollment

ACTUAL participants

Conditions

Hepatic ImpairmentNASH - Nonalcoholic SteatohepatitisCirrhosis, Liver

Interventions

MGL-3196

DRUG

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

NCT07324616

Hepatic Impairment (HI)

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RECRUITINGPHASE1

Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

NCT04271488

Hepatic Impairment

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RECRUITING

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

Molecular Mechanism of Exercise in Cirrhosis

Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis

Evaluation of Non-Invasive Tests for Metabolic Liver Disease