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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGL-3196 100 mg tablet plus Clopidogrel 75 mg tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGL-3196 | Drug | Administered orally on the morning of Day 1; Multiple-dose administration of 100 mg MGL-3196 on Day 6 until Day 14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days | |
| Pharmacokinetics (Cmax) of clopidogrel as affected by chronic dosing with MGL-3196 100 mg/day in healthy subjects | 14 days |
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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)
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| C588408 | resmetirom |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Clopidogrel | Drug | 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 |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |