Pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment.

ABSTRACT:

Purpose

The purpose of this study is to characterize niraparib pharmacokinetics (PK) and safety in patients with normal hepatic function (NHF) versus moderate hepatic impairment (MHI).

Methods

Patients with advanced solid tumors were stratified by NHF or MHI (National Cancer Institute-Organ Dysfunction Working Group criteria [bilirubin > 1.5-3 × upper limit of normal and any aspartate aminotransferase elevation]). In the PK phase, all patients received one 300 mg dose of niraparib. In the extension phase, patients with MHI received niraparib 200 mg daily; patients with NHF received 200 or 300 mg based on weight (< 77 kg, ≥ 77 kg)/platelets (< 150,000/µL, ≥ 150,000/µL). PK parameters included maximum concentration (C_max), area under the curve to last measured conce

SUBMITTER: Akce M 

PROVIDER: S-EPMC8484145 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature