Purpose Niraparib is a highly selective inhibitor of PARP-1 and PARP-2 approved in the United States for maintenance treatment of adult patients with recurrent ovarian cancer in complete or partial response to platinum-based chemotherapy. In this open-label crossover study, we evaluated the effects of food on niraparib pharmacokinetics (PK) and safety. Methods Patients received a single 300-mg dose of niraparib either after a high-fat meal or under fasting conditions. After a 7-day PK assessment, all patients received a second 300-mg dose of niraparib under the opposite condition, followed by 7-day PK assessment. Blood samples for PK analyses were collected at baseline (on days 1 and 8) and up to 168 h post-dose. Bioequivalence between conditions was defined by the 90% confidence intervals (CIs) for area under the plasma concentra- tion–time curve (AUC) from 0 to last measurable concentration (AUC ) and from 0 to infinity (AUC ) being within 0–last 0–∞ the 80–125% range. Results The high-fat meal/fasting ratios of geometric least-squares means for AUC and AUC were 106.8 (90% CI 0–last 0–∞ 97.8–116.6) and 110.1 (90% CI 99.7–121.6), respectively, indicating bioequivalence between conditions. Mean half-life, maximum plasma concentration (C ), and time to C after the high-fat meal were
Cancer Chemotherapy and Pharmacology – Springer Journals
Published: Jan 10, 2018
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