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The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin
The purpose of this study is to evaluate the potential effects of multiple once daily doses of MT-3995 on the PK of (S)-warfarin and (R)-warfarin after single-dose administration of racemic warfarin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin and MT-3995 | Experimental | Subjects will be administered a single dose of warfarin on day1. Subjects will be administered MT-3995 Days 8 to 20. Subjects will be administered MT-3995 and warfarin on Day21. Subjects will be administered MT-3995 from Day 22 to 27. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug |
| ||
| MT-3995 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of warfarin with MT-3995 versus warfarin alone | 8 days | |
| AUC of warfarin with MT-3995 versus warfarin alone | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone | 8 days | |
| INR AUC of warfarin with MT-3995 versus warfarin alone | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horst Heuer, Dr | Nuvisan GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical research organization | Neu-Ulm | Wegenerstraße | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33153727 | Derived | Nakamura T, Shimizu H, Kawaguchi A. Drug-Drug Interactions of the Nonsteroidal Mineralocorticoid Receptor Antagonist Apararenone With Midazolam, Warfarin, and Digoxin: A Phase 1 Studies in Healthy Volunteers. Clin Ther. 2020 Nov;42(11):2171-2183.e4. doi: 10.1016/j.clinthera.2020.09.002. Epub 2020 Nov 3. |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| C000719999 | apararenone |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |