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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 esomeprazole on the pharmacokinetics of isavuconazole. In addition, safety and tolerability of isavuconazole alone and in combination with esomeprazole will be assessed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isavuconazole alone | Experimental | Isavuconazole three times a day on Days 1 and 2 and once a day on Days 3, 4, and 5 |
|
| Isavuconazole and Esomeprazole | Experimental | Esomeprazole daily for 10 days starting on Day 1 and isavuconazole three times a day on Days 6 and 7 and once a day on Days 8, 9, and 10 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isavuconazole | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of plasma isavuconazole concentration: Area under the concentration-time curve during the time interval between consecutive dosing (AUCtau) | Day 5 (Arm 1) and Day 10 (Arm 2) | |
| Pharmacokinetics of plasma isavuconazole concentration: Maximum concentration (Cmax) | Day 5 (Arm 1) and Day 10 (Arm 2) | |
| Pharmacokinetics of plasma isavuconazole concentration: Time after dosing when Cmax occurs (tmax) | Day 5 (Arm 1) and Day 10 (Arm 2) | |
| Safety assessed through adverse events | up to Day 17 | |
| Safety assessed through clinical laboratory evaluations | Laboratory assessments will include hematology, serum chemistry and urinalysis parameters | up to Day 11 |
| Safety assessed by 12-lead electrocardiograms (ECGs) | up to Day 11 | |
| Safety assessed through vital signs | Vital signs will be measured including oral temperature, pulse, and sitting blood pressure | up to Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Clinical Unit | Baltimore | Maryland | 21225 | United States |
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| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Esomeprazole | Drug | oral |
|
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |