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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 (PK) of mycophenolate mofetil (MMF) after single dose administration. Safety and tolerability of isavuconazole will be assessed alone and in combination with MMF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isavuconazole and mycophenolate mofetil | Experimental | Single dose of MMF on Day 1, isavuconazole three times daily (TID) on Days 9 and 10, isavuconazole once daily (QD) Days 11-16, a single dose of MMF on Day 13 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isavuconazole | Drug | oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic (PK) variables of plasma mycophenolic acid (MPA) and phenolic glucuronide of MPA (MPAG): AUClast, AUCinf, Cmax | Area under the concentration-time curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast), AUC from the time of dosing to infinity (AUCinf), and maximum concentration (Cmax) | Days 1 and 13: predose, and at 0.5, .75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| PK of plasma isavuconazole: Trough concentration (Ctrough) | Day 11, Days 14-16, predose and on Day 17, predose and 24 hours postdose | |
| Composite of PK variables of plasma isavuconazole concentration: AUCtau, Cmax, and tmax | AUC during the time interval between consecutive dosing (AUCtau), time to attain Cmax (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior 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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| Mycophenolate mofetil | Drug | oral |
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| Days 12 and 13: predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, and 24 hours postdose |
| Composite of PK variables of plasma MPA: 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) | Days 1 and 13: predose, and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose |
| Composite of PK variables of plasma MPAG: tmax and t1/2 | Days 1 and 13: predose, and at 0.5, .75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose |
| Safety assessed through the reporting of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs | Through Day 17 |
| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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