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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 Repaglinide and possible metabolites after single dose administration. In addition, this study will assess the effect of multiple doses of isavuconazole on the pharmacokinetics of caffeine and possible metabolites after single dose administration. Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in combination with caffeine will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isavuconazole + Repaglinide + Caffeine | Experimental | Isavuconazole three times a day on Days 5 and 6 and once a day on Days 7 through 17, repaglinide on Days 1 and Day 14, caffeine on Days 3 and 16 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isavuconazole | Drug | oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of plasma repaglinide and possible metabolite concentration: Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast) | Days 1 and 14 | |
| Pharmacokinetics of plasma repaglinide and possible metabolite concentration: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) | Days 1 and 14 | |
| Pharmacokinetics of plasma repaglinide and possible metabolite concentration: Maximum concentration (Cmax) | Days 1 and 14 | |
| Pharmacokinetics of caffeine and possible metabolite concentration: Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast) | Days 3 and 16 | |
| Pharmacokinetics of caffeine and possible metabolite concentration: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) | Days 3 and 16 | |
| Pharmacokinetics of caffeine and possible metabolite concentration: Maximum concentration (Cmax) | Days 3 and 16 | |
| Pharmacokinetics of plasma isavuconazole concentration: Trough concentration (Ctrough) | Days 10-18 | |
| Pharmacokinetics of plasma isavuconazole concentration: Area under the concentration-time curve during the time interval between consecutive dosing (AUCtau) | Days 13, 14 and 16 | |
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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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| Repaglinide | Drug | oral |
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| Caffeine | Drug | oral |
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| Pharmacokinetics of plasma isavuconazole concentration: Maximum concentration (Cmax) |
| Days 13, 14 and 16 |
| Pharmacokinetics of plasma isavuconazole concentration: Time after dosing when Cmax occurs (tmax) | Days 13, 14 and 16 |
| Safety assessed through adverse events | up to Day 24 |
| Safety assessed through clinical laboratory evaluations | Laboratory assessments will include hematology, serum chemistry and urinalysis parameters | up to Day 18 |
| Safety assessed by 12-lead electrocardiograms (ECGs) | up to Day 18 |
| Safety assessed through vital signs | Vital signs will be measured including oral temperature, pulse, and sitting blood pressure | up to Day 18 |
| ID | Term |
|---|---|
| C508735 | isavuconazole |
| C072379 | repaglinide |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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