Drug Interaction Study of MGL-3196 With Pioglitazone

A Single Center, Open-Label, Drug Interaction Study of MGL-3196 With Pioglitazone and to Assess Food Effect in Healthy Subjects

The purpose of this study is to determine whether the single-dose pharmacokinetics (AUC) of pioglitazone are affected by chronic dosing with MGL-3196 100 mg/day in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: MGL-3196; Drug: Pioglitazone 15mg

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be willing and able to provide written informed consent
• Healthy, non-smoking male or female between the ages of 19 and 55 years (inclusive)
• Body weight > 50 kg and BMI between 18 and 32 kg/m2 (inclusive)
• If female, is non-pregnant and non-lactating. For females of non-childbearing potential, must have undergone sterilization procedures (hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy, hysterectomy, bilateral oophorectomy) at least 6 months prior to first dosing. Or, is postmenopausal with amenorrhea for at least 1 year prior to first dosing as verified by follicle stimulating hormone (FSH) at screening
• If female of childbearing potential, must use acceptable non-hormonal birth control (surgical sterilization of the partner, physical barrier method for at least 30 days prior to first dosing in addition to spermicide from the time of screening throughout study completion, non-hormonal intrauterine device for at least 3 months prior to first dosing, total abstinence from sexual intercourse for at least at least 3 months prior to first dosing and throughout study completion)
• 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 14 days beyond the last dose of study drug. No restrictions required for vasectomized male provided his vasectomy has been performed 3 months or more prior to Day 1. A male who has been vasectomized less than 3 months prior to study start must follow the same procedure as a non-vasectomized male.

Exclusion Criteria:

• Any clinically significant abnormal findings on physical examination, clinical laboratory tests or 12-lead ECG.
• Evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, hepatic, neurological or psychiatric disease.
• 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 per site standard procedures.
• 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 (Cholecystectomy is allowed).
• Abnormal screening ECG: including machine-read QTcF >450 msec in men and QTcF > 470 msec in women (confirmed by manual over read) 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, thyroid medication, 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.
• Participation in another clinical trial of an investigational drug (or medical device) within the last 30 days prior to the Day 1, or who have been exposed to more than four new chemical entities within 12 months prior to Day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MGL-3196 100 mg tablet plus Pioglitazone 15 mg tablet; MGL-3196 administered orally plus Pioglitazone administered orally on 2 separate days	Drug: MGL-3196; MGL-3196 100 mg tablet administered orally in the morning for 13 days; Drug: Pioglitazone 15mg; Pioglitazone 15 mg tablet administered orally on 2 separate days, initially on one day alone and again after MGL-3196 has been dosed to steady-state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC from the time of dosing of pioglitazone as affected by chronic dosing with MGL-3196 100 mg/day in healthy subjects	17 days

Collaborators and Investigators

• Sponsor: Madrigal Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Actual): December 11, 2018
• Study Completion (Actual): January 5, 2019

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Pioglitazone
• Other Study ID Numbers: MGL-3196-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No