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NCT04643795 · ClinicalTrials.gov registry record · Phase 1
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 1 study of Hepatic Impairment and Cirrhosis, Liver, sponsored by Madrigal Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
- 3
- Study locations
NCT04643795 is a Phase 1 study of Hepatic Impairment and Cirrhosis, Liver that has completed, run by Madrigal Pharmaceuticals. The registered enrollment target is 87 participants, above the 35-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (149% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT04643795, a Phase 1 study of Hepatic Impairment and Cirrhosis, Liver, has completed, sponsored by Madrigal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
- 3
- Study locations
Study 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 Studied
Interventions
- DRUG MGL-3196
Study Locations (3)
Florida
- Madrigal Research Center - Orlando
Minnesota
- Madrigal Research Center - Saint Paul
Texas
- Madrigal Research Center - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2018-10-25 |
| Est. Completion | 2021-08-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04643795
The ClinicalTrials.gov registry entry for NCT04643795 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 35-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (149% higher). The listed sponsor is Madrigal Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which MGL-3196 is the first listed.
NCT04643795 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Minnesota, Texas.
Frequently Asked Questions
What is clinical trial NCT04643795 about?
NCT04643795 is a clinical study titled "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". 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 subjec...
What is the current status of trial NCT04643795?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2018-10-25. Estimated completion is 2021-08-04.
What conditions does trial NCT04643795 study?
This clinical trial studies the following conditions: Hepatic Impairment, Cirrhosis, Liver, NASH - Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT04643795?
The interventions under investigation include: MGL-3196 (DRUG).
Who is sponsoring clinical trial NCT04643795?
This trial is sponsored by Madrigal Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04643795 being conducted?
This trial has 3 study locations across Florida, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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