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| Name | Class |
|---|---|
| Basilea Pharmaceutica International Ltd | INDUSTRY |
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This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an active control on the last dosing day to healthy subjects in one of the four groups. All treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on three study days. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to assess the amount of study drug in body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Isavuconazole low dose 3 times per day (TID) for 2 days followed by isavuconazole low dose once a day (QD) for 11 days |
|
| Group 2 | Experimental | Isavuconazole low dose 3 times per day (TID) for 2 days followed by isavuconazole high dose once a day (QD) for 11 days |
|
| Group 3 | Placebo Comparator | Placebo 3 times a day (TID) for 2 days followed by placebo once a day (QD) for 11 days |
|
| Group 4 | Active Comparator | Placebo 3 times a day (TID) for 2 days followed by placebo once a day (QD) for 10 days and then moxifloxacin 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 |
|---|---|---|
| Change from baseline in QT interval corrected for heart rate using Fridericia's correction (QTcF) | Baseline and Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Electrocardiogram (ECG) variables: QT, PR, RR intervals, QRS, and Heart Rate | Baseline and 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 |
|---|---|---|---|---|---|---|
| Parexel | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo | Drug | oral |
|
| Moxifloxacin | Drug | oral |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |