Bioavailability Study of MGL-3196 Tablets Compared to Capsules

NCT03413124 | Completed Phase 1 FDA Drug

• 1 other identifier: MGL-3196-08
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the pharmacokinetics of MGL-3196 capsules with MGL-3196 tablets in healthy male subjects and female subjects not of child-bearing potential.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the curve from the time of dosing extrapolated to infinity (AUC(0-inf))

  comparison between MGL-3196 capsules and MGL-3196 tablets

  48 hours

Study Arms (2)

Capsule then Tablet

ACTIVE COMPARATOR

MGL-3196 Capsule on Day 1 followed by MGL-3196 Tablet on Day 5

Drug: MGL-3196 Tablet; Drug: MGL-3196 Capsule

Tablet then Capsule

ACTIVE COMPARATOR

MGL-3196 Tablet on Day 1 followed by MGL-3196 Capsule on Day 5

Drug: MGL-3196 Tablet; Drug: MGL-3196 Capsule

Interventions

MGL-3196 Tablet DRUG

MGL-3196 in Tablet form

Capsule then Tablet; Tablet then Capsule

MGL-3196 Capsule DRUG

MGL-3196 in Capsule form

Capsule then Tablet; Tablet then Capsule

Eligibility Criteria

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

You may qualify if:

• Must be willing and able to provide written informed consent.
• Healthy, non-smoking, male or female between the ages of 18 and 55 years inclusive.
• Body weight \> 50 kg and BMI between 18 and 32 kg/m2 inclusive.
• if female, is of non-child bearing potential (i.e., surgically \[bilateral oophorectomy, hysterectomy, hysteroscopic sterilization, or tubal ligation\]. Or, is naturally sterile \[\>12 consecutive months without menses\]) with verification by FSH at screening.
• If male and non-vasectomized, must agree to use a condom with spermicide or abstain from sexual intercourse from the first dose of study drug until 30 days beyond the last dose of study drug. No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to first dose of study drug. A male who has been vasectomized less than 4 months prior to study start must follow the same procedure as a non-vasectomized male.

You may not qualify if:

• Any clinically significant abnormal findings during physical examination including blood pressure, heart rate or rhythm, clinical laboratory tests or 12-lead ECG.
• Evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, hepatic, neurological or psychiatric disease.
• 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).
• 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.
• Positive screening test for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.
• 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.
• History of intolerance to or adverse reaction to a statin, or history of myopathy including rhabdomyolysis.
• Intolerance to beta-blockers (beta-blocker treatment could be appropriate to alleviate tachycardia if observed).
• Participation in another clinical trial of an investigational drug (or medical device) within the last 30 days prior to the first dosing day, or who have been exposed to more than four new chemical entities within 12 months prior to the first dosing day.
• Donation of blood or blood loss in excess of 500 mL within 2 months prior to first dose of study drug.

Sponsors & Collaborators

• Madrigal Pharmaceuticals, Inc.: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

resmetirom

Study Officials

• Terry O'Reilly, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: February 5, 2018
• Primary Completion: February 17, 2018
• Study Completion: March 13, 2018
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)