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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Tesaro, Inc.
Study ID
NCT03359850
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.

Study Details

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.

Key Dates

Start date
Feb 20, 2018
Status verified
May 2021
Primary completion
Sep 16, 2019
Completion
Jun 24, 2020

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Normal hepatic function (Group 1):
    To evaluate the pharmocokinetics and safety of niraparib
  • Experimental: Moderate hepatic impairment (Group 2):
    To evaluate the pharmocokinetics and safety of niraparib

Primary Outcome Measure

Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Niraparib and Its Major Metabolite (M1) During PK Phase [ Time Frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1 ]

Locations (5)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLos AngelesCalifornia90033-
GSK Investigational SiteNewport BeachCalifornia92663-
GSK Investigational SiteAuroraColorado80045-
GSK Investigational SiteAtlantaGeorgia30322-
GSK Investigational SiteHoustonTexas77030-

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