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| Name | Class |
|---|---|
| Basilea Pharmaceutica | INDUSTRY |
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The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects.
Subjects will check-in on Day -1 and remain confined to the study center until the completion of study procedures on Day 14. Subjects will return to the study center for an outpatient follow-up visit on Day 21. Blood and urine samples will be taken at various times during the study.
Subjects will receive a single dose of oral midazolam syrup on Day 1. On Days 3 and 4, isavuconazole will be dosed orally three times daily (TID). On Days 5 through 13, isavuconazole will be dosed orally once daily (QD). A single dose of oral midazolam syrup will be administered on Day 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isavuconazole and Midazolam | Experimental | Isavuconazole three times per day (TID) for 2 days followed by once a day (QD) for 9 days. Midazolam single doses on days 1 and 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isavuconazole | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessment of AUC through the analysis of blood samples | Up to Day 13 | |
| Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples | Up to Day 13 |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | Oral |
|
| D006571 | Heterocyclic Compounds |