Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 1371 for:    Area Under Curve AND tablet

Bioavailability Study of MGL-3196 Tablets Compared to Capsules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03413124
Recruitment Status : Active, not recruiting
First Posted : January 29, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
Madrigal Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 22, 2018
First Posted Date  ICMJE January 29, 2018
Last Update Posted Date February 13, 2018
Actual Study Start Date  ICMJE February 5, 2018
Estimated Primary Completion Date February 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
Area under the curve from the time of dosing extrapolated to infinity (AUC(0-inf)) [ Time Frame: 48 hours ]
comparison between MGL-3196 capsules and MGL-3196 tablets
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03413124 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of MGL-3196 Tablets Compared to Capsules
Official Title  ICMJE A Single Center, Open-Label, Single-Dose, Cross-over, Bioavailability Study of MGL-3196 Tablets Compared to Capsules in Healthy Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: MGL-3196 Tablet
    MGL-3196 in Tablet form
  • Drug: MGL-3196 Capsule
    MGL-3196 in Capsule form
Study Arms  ICMJE
  • Active Comparator: Capsule then Tablet
    MGL-3196 Capsule on Day 1 followed by MGL-3196 Tablet on Day 5
    Interventions:
    • Drug: MGL-3196 Tablet
    • Drug: MGL-3196 Capsule
  • Active Comparator: Tablet then Capsule
    MGL-3196 Tablet on Day 1 followed by MGL-3196 Capsule on Day 5
    Interventions:
    • Drug: MGL-3196 Tablet
    • Drug: MGL-3196 Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 22, 2018)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 17, 2018
Estimated Primary Completion Date February 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.

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 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.
  • Use of prescription or non-prescription drugs, vitamins, herbal and dietary supplements within 7 days prior to the first dose of study drug.
  • 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 alcohol within 24 hours prior to screening, within 7 days before dosing, and throughout the study.
  • Use of acetaminophen within 7 days before dosing and throughout the study.
  • 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).
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (e.g., infectious disease) must not be enrolled.
  • Any other sound medical, psychiatric, and /or social reason as determined by the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03413124
Other Study ID Numbers  ICMJE MGL-3196-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Madrigal Pharmaceuticals, Inc.
Study Sponsor  ICMJE Madrigal Pharmaceuticals, Inc.
Collaborators  ICMJE Celerion
Investigators  ICMJE
Principal Investigator: Terry O'Reilly, MD Celerion
PRS Account Madrigal Pharmaceuticals, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP