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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 prednisolone after single dose administration of prednisone. This study will also assess the safety and tolerability of isavuconazole alone and in combination with prednisone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isavuconazole and Prednisone | Experimental | Single dose of prednisone on Days 1 and 9, isavuconazole 3 times a day (TID) on Days 5-6, isavuconazole once a day (QD) on Days 7-10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isavuconazole | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of plasma prednisolone: AUClast, | Area under the concentration-time curve (AUC) from the time of dosing to the last quantifiable concentration (AUC last) | Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose |
| Pharmacokinetics of plasma prednisolone: AUCinf | AUC from the time of dosing to infinity (AUCinf), | Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose |
| Pharmacokinetics of plasma prednisolone: Cmax | Maximum concentration (Cmax) | Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of plasma isavuconazole concentration: Trough concentration (Ctrough) | Day 7 predose; Day10 predose and Day 11 postdose | |
| Composite of pharmacokinetics of plasma isavuconazole concentration: AUCtau, Cmax, and tmax | AUC during the time interval between consecutive dosing (AUCtau), Cmax, and time to attain Cmax (tmax) |
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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, LLC | Glendale | California | 91206 | United States |
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| Prednisone | Drug | oral |
|
| Day 8 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose; Day 9 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours postdose |
| Composite of pharmacokinetics of plasma prednisone: AUClast, AUCinf, Cmax, tmax, t1/2, Vz/F, and CL/F | Apparent terminal elimination half life ( t1/2), apparent volume of distribution (Vz/F), and apparent body clearance after oral dosing (CL/F) | Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose |
| Composite of pharmacokinetics of plasma prednisolone: t max and t1/2 | Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose |
| Safety assessed by recording of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs | 18 days |
| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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