HealthyPhase 1NCT02749578
Drug Interaction Study of MGL-3196 With Atorvastatin
A Phase 1 study testing Atorvastatin and MGL-3196 in people with Healthy, run by Madrigal Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Atorvastatin and MGL-3196
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label, Drug Interaction Study of MGL-3196 With Atorvastatin in Healthy Subjects
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.
- Conditions
- Healthy
- Being tested
- Atorvastatin, MGL-3196
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
MGL-3196Drug
Also called VIA-3196
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Atorvastatin followed by MGL-3196 daily followed by separate co-administration of atorvastatin Receives: Drug: Atorvastatin; Drug: MGL-3196 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from the time of dosing extrapolated to infinity (AUC(0-inf)) of Atorvastatin as affected by MGL-3196
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Danielle Armas, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749578
- Sponsor's protocol ID
- MGL-3196-04
- Status last verified
- Aug 2016
- First submitted
- 20 Apr 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Drug Interaction Study of MGL-3196 With Atorvastatin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02749578
- Acronym / sponsor ID
- MGL-3196-04
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Drug: Atorvastatin, Drug: MGL-3196Atorvastatin followed by MGL-3196 daily followed by separate co-administration of atorvastatin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor | Drug | Treatment |
| MGL-3196Also: VIA-3196 | Drug | Treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Armas, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvastatin and MGL-3196 in people with Healthy, run by Madrigal Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.