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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 a single dose of metformin. Safety and tolerability of isavuconazole will be assessed alone and in combination with metformin.
Subjects will check-in to the clinic on Day -1 and remain confined through completion of the study procedures on Day 10.
A follow-up telephone call will be made on Day 16 to check on health status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isavuconazole and metformin | Experimental | Metformin single dose on days 1 and 8. Isavuconazole three times a day (TID) on Days 4 and 5 followed by isavuconazole once daily (QD) on Days 6-9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isavuconazole | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of metformin in plasma: Area Under the Concentration-Time Curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast) | Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose) | |
| PK of metformin in plasma: AUC from the time of dosing to infinity (AUCinf) | Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose) | |
| PK of metformin in plasma: Maximum Concentration (Cmax) | Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose) |
| Measure | Description | Time Frame |
|---|---|---|
| PK variable for isavuconazole in plasma: Trough Concentration (Ctrough) | Days 6, 9 and 10 (1 sample prior to isavuconazole dosing) | |
| Composite of PK variables for isavuconazole in plasma: AUCtau, Cmax and tmax | AUC during the time interval between consecutive dosing (AUCtau); the time after dosing when Cmax occurs (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | 91026 | United States |
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| metformin | Drug | oral |
|
|
| Days 7 and 8 (13 samples collected per day) |
| Composite of PK variables for metformin in plasma: t1/2, tmax, CL/F and Vz/F | Apparent Terminal Elimination Half-life (t1/2); Apparent Body Clearance After Oral Dosing (CL/F); Apparent Volume of Distribution (Vz/F) | Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose) |
| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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