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CompletedNCT02749578Updated Aug 30, 2016

Drug Interaction Study of MGL-3196 With Atorvastatin

A Phase 1 interventional study of Atorvastatin and MGL-3196 in Healthy, sponsored by Madrigal Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-30.

Sponsored by Madrigal Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether MGL-3196 alters the pharmacokinetics of atorvastatin in healthy male subjects and female subjects not of child-bearing potential.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Madrigal Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; 5 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 follicle stimulating hormone (FSH) at screening.
  • If male and non-vasectomized, must agree to use a condom with spermicide or abstain from sexual intercourse during the study 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.

Exclusion criteria

Exclusion Criteria:

  • 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 aspartate aminotransferase (AST), alanine aminotransferase (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 creatine kinase (CK) at screening (one repeat test allowed).
  • Gilbert's syndrome.
  • Positive screening test for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.
  • Abnormal screening ECG: including machine-read QTc >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.
  • Use of St. John's Wort within 28 days before the first dose of study drug.
  • Unwilling to forgo consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or pomelos, star fruit, grapefruit hybrids or other citrus juices from 5 days prior to the first dose of study drug and throughout the study.
  • Subjects with a history of drug or alcohol abuse as defined by the Diagnostic and Statistical Manual 5th Edition.
  • 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.
  • Use of acetaminophen within 7 days before dosing and throughout the study except for the treatment of an adverse event as directed by the Investigator.
  • History of regular use of tobacco or nicotine containing products within the past 6 months relative to screening.
  • Positive urine drug screen or alcohol test at screening or Day -1.
  • Women who are pregnant or may become pregnant, or are nursing.
  • Strenuous physical activity which could cause muscle aches or injury, including contact sports, at any time from 3 days prior to first dose of study drug until completion of the study.
  • Excessive caffeine intake (>3 cups of coffee/day or equivalent).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Other
    Treatment

    Atorvastatin followed by MGL-3196 daily followed by separate co-administration of atorvastatin

    Drug: Atorvastatin · Drug: MGL-3196

Interventions

  • DrugAtorvastatin

    Also known as: Lipitor

  • DrugMGL-3196

    Also known as: VIA-3196

06

What researchers measure

Primary outcomes

  1. Area under the curve from the time of dosing extrapolated to infinity (AUC(0-inf)) of Atorvastatin as affected by MGL-3196

    Time frame: 72 hours

07

Study locations

1 site
  • Celerion
    Tempe, Arizona 85283, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02749578
Lead sponsor
Madrigal Pharmaceuticals, Inc.
Collaborators
Celerion
Responsible party
Sponsor
First posted
Apr 25, 2016
Start date
Apr 2016
Primary completion
May 2016
Completion
May 2016
Last update
Aug 30, 2016

Study contacts

Danielle Armas, MD
principal investigator · Celerion

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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