HealthyPhase 1NCT03220165
Radiolabeled Study to Determine the Mass Balance of [14C] MGL-3196
A Phase 1 study testing 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 determine in healthy males how MGL-3196 is metabolized using a radio-labeled version of MGL-3196. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MGL-3196
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2017to 3 Sep 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily consents to participate and provides written informed consent.
- Is a male.
- Is between 18 and 55 years of age (inclusive).
- Has a body mass index (BMI) between 18 and 32 kg/m2 (inclusive), and weighs a minimum of 50 kg.
- Is willing and able to remain in the study unit for the entire duration of the confinement periods
- Is willing to eat entire meals and snacks provided during confinement at the research facility; and understand that the diet will include foods with high fiber content and possibly prune juice.
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- Is willing to have collected all urine and fecal samples for the duration of the study period as required.
- Is willing to use a waterless commode located in a designated dry room for urine and feces collection for the duration of the study period as required.
- Is willing to abstain from showering for the first 72 hours after administration of [14C] MGL-3196. After the restriction from showering is lifted, must be willing to provide a urine sample prior to showering for the remainder of the confinement period.
Who cannot join
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- A clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening.
- 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).
- History of Gilbert's syndrome.
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- 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 the study drug.
- 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.
- Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- Has participated in a standard radiolabeled clinical trial within the last 12 months prior to the first dose of study medication or a micro tracer clinical trial within the last 3 months prior to the first dose of study medication.
- Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.
- Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, vitamins, or acetaminophen) within 7 days prior to the first dose of study medication until the end of study visit without evaluation and approval by the Investigator.
- Use of any prescription medication from 14 days prior to the first dose of study medication until the end-of-study visit without evaluation and approval by the Investigator.
- Has been treated with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) within 30 days prior to the first dose of study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results.
- Blood or plasma donation within 30 days prior to the first dose of study medication until the end-of-study visit. It is recommended that blood/plasma donations not be made for at least 30 days after the end-of-study visit.
- Smoking or use of tobacco- or nicotine-containing products within 60 days prior to the first dose of study medication until the end-of-study visit.
- Consumption of beverages or foods that contain grapefruit, poppy seeds, broccoli, Brussels sprouts, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 48 hours prior to the first dose of study medication until the end-of-study visit. Subjects will be instructed not to consume any of the above products; however, allowance for an isolated single incidental consumption may be evaluated and approved by the study Investigator based on the potential for interaction with the study drug.
- Has any prior history of substance abuse or treatment (including alcohol).
- History of regular alcohol consumption exceeding 14 drinks/week (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 dosing and throughout the study.
- Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine.
- Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- 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.
- Has irregular bowel habits. ("Irregular" being defined for the purpose of this study as NOT having a bowel movement at least every 2 days.)
- Has been exposed to radiation, including dental or medical imaging such as X-ray or tomography, in the 6 months prior to dose administration.
- Has been involved in an occupation that requires monitoring for radiation exposure (eg, X-ray technician).
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, 78217
About this study
Official title: An Open-Label, Single-Radiolabeled Dose, Non-Randomized Study to Determine the Mass Balance of [14C] MGL-3196
The purpose of this study is determine in healthy males how MGL-3196 is metabolized using a radio-labeled version of MGL-3196.
- Conditions
- Healthy
- Being tested
- MGL-3196
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGL-3196Drug
Also called VIA-3196
oral, 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | MGL-3196 Receives: Drug: MGL-3196 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance of [14C] MGL-3196
Measurement of the total radioactivity collected from blood, urine, and feces
Measured: Approximately 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start6 Aug 2017
- Primary completion3 Sep 2017
- Study completion3 Sep 2017
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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- George Ate, MD, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220165
- Sponsor's protocol ID
- MGL-3196-07
- Status last verified
- Dec 2017
- First submitted
- 14 Jul 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Radiolabeled Dose, Non-Randomized Study to Determine the Mass Balance of [14C] MGL-3196
- ClinicalTrials.gov ID
- NCT03220165
- Acronym / sponsor ID
- MGL-3196-07
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 6 Aug 2017 (actual)
- Primary completion
- 3 Sep 2017 (actual)
- Study completion
- 3 Sep 2017 (actual)
- First posted
- 18 Jul 2017 (actual)
- 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 determine in healthy males how MGL-3196 is metabolized using a radio-labeled version of MGL-3196.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: MGL-3196MGL-3196 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Voluntarily consents to participate and provides written informed consent.
- Is a male.
- Is between 18 and 55 years of age (inclusive).
- Has a body mass index (BMI) between 18 and 32 kg/m2 (inclusive), and weighs a minimum of 50 kg.
- Is willing and able to remain in the study unit for the entire duration of the confinement periods
Key exclusion criteria (30 listed)
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- A clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening.
- 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).
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 |
|---|---|---|
| MGL-3196Also: VIA-3196oral, 100 mg | Drug | Treatment |
Primary outcome
Mass Balance of [14C] MGL-3196
Time frame: Approximately 10 Days
Measurement of the total radioactivity collected from blood, urine, and feces
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 19 Dec 2017.
- 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.
George Ate, MD principal investigator
Worldwide Clinical Trials
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 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 9 inclusion and 30 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 19 Dec 2017. 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?
Mass Balance of [14C] MGL-3196 (time frame: Approximately 10 Days). 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 19 Dec 2017.