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| Name | Class |
|---|---|
| Basilea Pharmaceutica International Ltd | INDUSTRY |
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The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of digoxin in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isavuconazole and digoxin | Experimental | Isavuconazole three times per day (TID) on Days 15 and 16, and once daily (QD) on Days 17 thru 26. Digoxin single dose on Days 1 and 19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isavuconazole | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile for digoxin (in plasma):AUCinf, AUClast, Cmax | Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to the last quantifiable concentration (AUClast), and maximum concentration(Cmax) | Days 1 and 19 |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile for digoxin (in plasma): tmax, Vz/F, CL/F, and t1/2 | Time to attain Cmax(tmax), apparent volume of distribution (Vz/F), apparent body clearance after oral dosing (CL/F), and apparent terminal elimination half-life (t1/2) | Days 1 and 19 |
| PK Isavuconazole (in plasma): trough concentration (Ctrough) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International | Baltimore | Maryland | 21225 | United States |
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| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| digoxin | Drug | oral |
|
|
| Day 17 and Days 21 through 27 |
| PK profile for Isavuconazole (in plasma): AUCtau, Cmax, and tmax | AUC during time interval between consecutive dosing (AUCtau), maximum concentration (Cmax),and time to attain Cmax (tmax) | Days 18 and 19 |
| Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs. | Day 1 through Day 34 (± 2 days) |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |