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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single 300 mg dose of niraparib
Intravenous (IV) infusion of 100 μg niraparib (containing approximately 1 μCi of \[14C\]-niraparib)
Single 300 mg dose of niraparib (unlabeled active pharmaceutical ingredient)
The Netherlands Cancer Institute
Amsterdam, Netherlands
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
Time frame: 0 - 22 days
AUC0-last
AUC (Area Under the Curve) from time 0 to the last quantifiable concentration
Time frame: 0 - 22 days
Cmax
Observed Maximum plasma Concentration
Time frame: 0 - 22 days
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