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This study comprises 2 cohorts, and in each cohort, the study will be conducted as an open-label add-on study.
The purpose of the study is to investigate the pharmacokinetics of each substrate in concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in healthy adult males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | TRK-700 + Digoxin |
|
| Cohort B | Experimental | TRK-700 + Midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRK-700 | Drug | repeated oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration - time curve from administration to the last available concentration measurement of Digoxin and Midazolam(AUClast) | Cohort A: up to 72 hours, Cohort B: up to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Tokyo | Japan |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin |
| Drug |
single oral administration with/without TRK-700 |
|
| Midazolam | Drug | single oral administration with/without TRK-700 |
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |