Radiolabeled Study to Determine the Mass Balance of [14C] MGL-3196

NCT03220165 | Completed Phase 1 FDA Drug

• 1 other identifier: MGL-3196-07
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is determine in healthy males how MGL-3196 is metabolized using a radio-labeled version of MGL-3196.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Mass Balance of [14C] MGL-3196

  Measurement of the total radioactivity collected from blood, urine, and feces

  Approximately 10 Days

Study Arms (1)

Treatment

EXPERIMENTAL

MGL-3196

Drug: MGL-3196

Interventions

MGL-3196 DRUG

oral, 100 mg

Also known as: VIA-3196

Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily consents to participate and provides written informed consent.
• Is a male.
• Is between 18 and 55 years of age (inclusive).
• Has a body mass index (BMI) between 18 and 32 kg/m2 (inclusive), and weighs a minimum of 50 kg.
• Is willing and able to remain in the study unit for the entire duration of the confinement periods
• Is willing to eat entire meals and snacks provided during confinement at the research facility; and understand that the diet will include foods with high fiber content and possibly prune juice.
• Is willing to have collected all urine and fecal samples for the duration of the study period as required.
• Is willing to use a waterless commode located in a designated dry room for urine and feces collection for the duration of the study period as required.
• Is willing to abstain from showering for the first 72 hours after administration of \[14C\] MGL-3196. After the restriction from showering is lifted, must be willing to provide a urine sample prior to showering for the remainder of the confinement period.

You may not qualify if:

• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
• A clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening.
• Thyroid stimulating hormone test at screening outside the normal range. Repeat testing is allowed once at the discretion of the Investigator.
• Current or recent (\<6 months) hepatobiliary disease; or AST, ALT or direct bilirubin greater than the upper limit of reference range at screening. Repeat testing is allowed once at the discretion of the Investigator.
• Elevated CK at screening (one repeat test allowed).
• History of 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 the study drug.
• Abnormal screening ECG: including machine-read QTcF \>450 msec (confirmed by manual over read), QRS \>110 msec, intermittent bundle branch block, frequent premature atrial or premature ventricular contractions, or any rhythm other than normal sinus rhythm which is interpreted by the Investigator to be clinically significant.
• History of sensitivity to a similar study drug (e.g., Karo Bio KB2115 or Metabasis MB7811), or a history of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing) unless deemed not clinically significant by the Investigator.
• History of sensitivity to thyroid medication.
• Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
• Has participated in a standard radiolabeled clinical trial within the last 12 months prior to the first dose of study medication or a micro tracer clinical trial within the last 3 months prior to the first dose of study medication.
• Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.
• Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, vitamins, or acetaminophen) within 7 days prior to the first dose of study medication until the end of study visit without evaluation and approval by the Investigator.
• Use of any prescription medication from 14 days prior to the first dose of study medication until the end-of-study visit without evaluation and approval by the Investigator.

Sponsors & Collaborators

• Madrigal Pharmaceuticals, Inc.: lead
• Worldwide Clinical Trials: collaborator

Study Sites (1)

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

resmetirom

Study Officials

• George Ate, MD

  Worldwide Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: August 6, 2017
• Primary Completion: September 3, 2017
• Study Completion: September 3, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)