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Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients.

Abstract：

INTRODUCTION:Niraparib (Zejula™) is a poly(ADP-ribose) polymerase inhibitor recently approved by the US Food and Drug Administration for the maintenance treatment of patients with recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The pivotal phase III clinical trial has shown improved progression-free survival in patients receiving niraparib compared with those receiving placebo. PURPOSE:Since niraparib is administered orally, it is of interest to investigate the oral bioavailability (F po) of this novel compound, which is the aim of this study. METHODS:Six patients received an oral therapeutic dose of 300 mg niraparib, followed by a 15-min intravenous infusion of 100 µg 14C-niraparib with a radioactivity of approximately 100 nCi. The niraparib therapeutic dose was measured in plasma using a validated liquid chromatography-tandem mass spectrometry method, whereas the total 14C-radioactivity and 14C-niraparib plasma levels were measured by accelerator mass spectrometry and a validated high performance liquid chromatography assay with AMS. RESULTS:The F po of niraparib was determined to be 72.7% in humans.

journal_name

Cancer Chemother Pharmacol

journal_title

Cancer chemotherapy and pharmacology

authors

van Andel L,Rosing H,Zhang Z,Hughes L,Kansra V,Sanghvi M,Tibben MM,Gebretensae A,Schellens JHM,Beijnen JH

doi

10.1007/s00280-017-3455-x

subject

Has Abstract

pub_date

2018-01-01 00:00:00

pages

39-46

issue

1

eissn

0344-5704

issn

1432-0843

pii

10.1007/s00280-017-3455-x

journal_volume

81

pub_type

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