The effect of food on the pharmacokinetics of niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, in patients with recurrent ovarian cancer

The effect of food on the pharmacokinetics of niraparib, a poly(ADP-ribose) polymerase (PARP)... 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 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Cancer Chemotherapy and Pharmacology Springer Journals

The effect of food on the pharmacokinetics of niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, in patients with recurrent ovarian cancer

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Publisher
Springer Journals
Copyright
Copyright © 2018 by The Author(s)
Subject
Medicine & Public Health; Oncology; Pharmacology/Toxicology; Cancer Research
ISSN
0344-5704
eISSN
1432-0843
D.O.I.
10.1007/s00280-017-3512-5
Publisher site
See Article on Publisher Site

Abstract

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

Journal

Cancer Chemotherapy and PharmacologySpringer Journals

Published: Jan 10, 2018

References

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