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This is an open-label study with 2 parts, plus an extension study following completion of Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6 subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and absolute bioavailability of niraparib.
Part 1: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib (unlabeled active pharmaceutical ingredient) on Day 1. Two hours after the oral dose, subjects will receive a 15-minute IV infusion of niraparib (labeled pharmaceutical ingredient).
Part 2: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib, labeled active pharmaceutical ingredient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niraparib Oral and IV | Experimental | Single Oral dose of Niraparib capsules (unlabeled active pharmaceutical ingredient) orally and a 15-minute IV infusion of Niraparib (labeled active pharmaceutical ingredient) |
|
| Niraparib Oral | Experimental | Single Oral dose of Niraparib capsules (labeled active pharmaceutical ingredient) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib Oral Capsules (Labeled) | Drug | Single 300 mg dose of niraparib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Oral bioavailability (F) will be derived using F=AUCoral / AUCiv as a % | Absolute bioavailability of niraparib will be calculated as the ratio of dose normalized oral to IV niraparib exposure | 0 - 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last | AUC (Area Under the Curve) from time 0 to the last quantifiable concentration | 0 - 22 days |
| Cmax | Observed Maximum plasma Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shefali Agarwal, MD | Tesaro, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Netherlands Cancer Institute | Amsterdam | 1066 CX | Netherlands |
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| Niraparib IV (Labeled) |
| Drug |
Intravenous (IV) infusion of 100 μg niraparib (containing approximately 1 μCi of [14C]-niraparib) |
|
| Niraparib Oral Capsules (Unlabeled) | Drug | Single 300 mg dose of niraparib (unlabeled active pharmaceutical ingredient) |
|
| 0 - 22 days |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C545685 | niraparib |
| D011356 | Product Labeling |
| ID | Term |
|---|---|
| D019064 | Product Packaging |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
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