HealthyPhase 1NCT04671069
Drug Interaction Study of MGL-3196 With Clopidogrel
A Phase 1 study testing MGL-3196 and Clopidogrel 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 the single and multiple-dose pharmacokinetics (PK) of MGL-3196 are affected by co-administration with clopidogrel in healthy subjects. 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?
- MGL-3196 and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2019to 14 Sep 2019
- 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)
- Female subjects must:
- Be non-pregnant and non-lactating
- For females of non-childbearing potential, female must have undergone one of the following sterilization procedures at least 6 months prior to first dosing: hysterscopic fertilization bilateral salpingectomy, tubal occlusion, hysterectomy, bilateral oophorectomy
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- For postmenopausal women, are considered postmenopausal if amenorrheic for at least 12 months without an alternative medical cause
- For females of childbearing potential, must one of the following birth control methods: surgical sterilization of partner, hormonal contraceptives no prone to drug-drug interactions, hormonal oral contraceptive agents such as normal and low dose combined pills or progesterone only pills, physical barrier method (eg, male condom) in addition to spermicide, non-hormonal intrauterine device for at least 3 months prior to first dosing, total abstinence from sexual intercourse for at least 3 months prior to first dosing and through 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.
Who cannot join
- 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.
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 Clopidogrel in Healthy Subjects
The purpose of this study is to determine whether the single and multiple-dose pharmacokinetics (PK) of MGL-3196 are affected by co-administration with clopidogrel in healthy subjects.
- Conditions
- Healthy
- Being tested
- MGL-3196, Clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGL-3196Drug
Administered orally on the morning of Day 1; Multiple-dose administration of 100 mg MGL-3196 on Day 6 until Day 14
ClopidogrelDrug
After one-day washout period after Day 1, loading dose of 300 mg clopidogrel administered on Day 3 and then, at approximately the same time each morning, 75 mg clopidogrel administered on Days 4 to 11
| Study group | Role | What they receive |
|---|---|---|
| MGL-3196 100 mg tablet plus Clopidogrel 75 mg tablet | Experimental | Not described Receives: Drug: MGL-3196; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from the time of dosing of clopidogrel as affected by single and multiple daily dosing with MGL-3196 100 mg/day in healthy subjects
Measured: 14 days
Pharmacokinetics (Cmax) of clopidogrel as affected by chronic dosing with MGL-3196 100 mg/day in healthy subjects
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start26 Jul 2019
- Primary completion30 Aug 2019
- Study completion14 Sep 2019
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671069
- Sponsor's protocol ID
- MGL-3196-12
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- 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 28 Dec 2020. 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 Clopidogrel in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04671069
- Acronym / sponsor ID
- MGL-3196-12
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 14 Sep 2019 (actual)
- First posted
- 17 Dec 2020 (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 to determine whether the single and multiple-dose pharmacokinetics (PK) of MGL-3196 are affected by co-administration with clopidogrel in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGL-3196 100 mg tablet plus Clopidogrel 75 mg tablet | Experimental | Drug: MGL-3196, Drug: Clopidogrel |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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)
- Female subjects must:
- 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.
Key exclusion criteria (8 listed)
- 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).
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-3196Administered orally on the morning of Day 1; Multiple-dose administration of 100 mg MGL-3196 on Day 6 until Day 14 | Drug | MGL-3196 100 mg tablet plus Clopidogrel 75 mg tablet |
| ClopidogrelAfter one-day washout period after Day 1, loading dose of 300 mg clopidogrel administered on Day 3 and then, at approximately the same time each morning, 75 mg clopidogrel administered on Days 4 to 11 | Drug | MGL-3196 100 mg tablet plus Clopidogrel 75 mg tablet |
Primary outcome
AUC from the time of dosing of clopidogrel as affected by single and multiple daily dosing with MGL-3196 100 mg/day in healthy subjects
Time frame: 14 days
Pharmacokinetics (Cmax) of clopidogrel as affected by chronic dosing with MGL-3196 100 mg/day in healthy subjects
Time frame: 14 days
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 28 Dec 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Clopidogrel 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 8 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 28 Dec 2020. 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?
AUC from the time of dosing of clopidogrel as affected by single and multiple daily dosing with MGL-3196 100 mg/day in healthy subjects (time frame: 14 days). The study lists 2 primary outcomes in all. 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 28 Dec 2020.