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The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-8554, rosuvastatin and simvastatin | Experimental | Subjects will be administered a single dose of rosuvastatin followed on Day 4 by a single dose of simvastatin. MT-8554 will be administered from Days 6 to 12 with co-administration of rosuvastatin and simvastatin on Days 9 and 12, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-8554 | Drug |
| ||
| rosuvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554. | 72 hours post dose | |
| Cmax of rosuvastatin alone and in the presence of MT-8554. | 72 hours post dose | |
| AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554. | 24 hours post dose | |
| Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554. | 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as measured by vital signs | Up to Day 16 | |
| Safety and Tolerability as measured by number of participants with adverse events | Up to Day 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational center | City Name | United Kingdom |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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|
| simvastatin | Drug |
|
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |