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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 ketoconazole at steady state on the pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: isavuconazole only | Experimental | Single dose of isavuconazole on Day 1 |
|
| Arm 2: isavuconazole + ketoconazole | Experimental | Single dose of isavuconazole on Day 4 and ketoconazole twice daily (BID) for 24 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isavuconazole | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile for isavuconazole (in plasma): AUClast , Cmax | Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast) and maximum concentration (Cmax) | Day 1 (Arm 1) and Day 4 (Arm 2): predose and 0.5, 1, 2, 4, 6, 8, 10, 12, 20, 24, 36, 48, 72, 96,120,144,168,192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 and 504 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile for isavuconazole (in plasma): AUCinf, tmax, CL/F, Vz/F, and t1/2 | Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf), Time to attain Cmax (tmax), apparent body clearance after oral dosing (CL/F), apparent volume of distribution (Vz/F), and apparent terminal elimination half-life (t1/2) | Day 1(Arm 1) and Day 4 (Arm 2): predose and 0.5, 1, 2, 4, 6, 8, 10, 12, 20, 24, 36, 48, 72, 96,120,144,168,192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 and 504 hours post-dose |
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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 |
|---|---|---|---|---|---|---|
| Spaulding Clinical | West Bend | Wisconsin | 53095 | United States |
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| Ketoconazole | Drug | oral |
|
| PK for ketoconazole (in plasma): trough concentration (Ctrough) | Day 2 (Arm 2): predose |
| PK profile for ketoconazole (in plasma): AUCtau, Cmax, and tmax | AUC during time interval between consecutive dosing (AUCtau) | Days 3 and 4: predose and 0.5,1, 2, 4, 6, 8,12 and 24 hours post-dose |
| Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs | Day 1 through Day 25 (± 2 days) |
| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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