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Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients

Neoplasms Clinical Trial

Official title:
An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following a Single Oral Dose in Patients With Advanced Solid Tumors and Either Normal Hepatic Function or Moderate Hepatic Impairment

Clinical Trial Summary

Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment, for the purpose of providing recommendations to guide the initial dose and dose titration in this patient population.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03359850
Study type Interventional
Source Tesaro, Inc.
Contact
Status Completed
Phase Phase 1
Start date February 20, 2018
Completion date June 24, 2020
View Details
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