Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule

Part of paid clinical trials in Encinitas, California.

Sponsor
Tesaro, Inc.
Study ID
NCT03329001
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

Study Details

This is a three stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) and Bioequivalence (BE) of niraparib administered as a tablet formulation compared to the reference capsule formulation currently marketed in the United States. Stage 3 evaluates the effect of a high-fat meal on niraparib pharmacokinetics (PK) following a single dose of the tablet. The Extension Phase of this study is to enable participants enrolled in the study to continue to receive treatment with niraparib tablets if they are tolerating it and, in the Investigator's opinion, may receive benefit.

Key Dates

Start date
Dec 4, 2017
Status verified
Jul 2024
Primary completion
Dec 30, 2021
Completion
Jun 15, 2023

Study Design

Enrollment
236 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Stage 1: Tablet-Capsule Sequence
    Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase
  • Experimental: Stage 1: Capsule-Tablet Sequence
    Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
  • Experimental: Stage 2: Tablet-Capsule Sequence
    Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase.
  • Experimental: Stage 2: Capsule-Tablet Sequence
    Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
  • Experimental: Stage 3: High fat meal-fasted sequence
    Single dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state.
  • Experimental: Stage 3: Fasted-high fat meal sequence
    Single dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal.

Primary Outcome Measure

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period ]

Locations (16)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteEncinitasCalifornia92024-
GSK Investigational SiteFresnoCalifornia93720-
GSK Investigational SiteDenverColorado80218-
GSK Investigational SiteNew HavenConnecticut06520-
GSK Investigational SiteSarasotaFlorida34232-
GSK Investigational SiteAtlantaGeorgia30322-
GSK Investigational SiteGrand RapidsMichigan49546-
GSK Investigational SiteJacksonMississippi39216-
GSK Investigational SiteCincinnatiOhio45267-
GSK Investigational SiteClevelandOhio44106-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteDallasTexas75230-
GSK Investigational SiteHoustonTexas77030-
GSK Investigational SiteSan AntonioTexas78229-
GSK Investigational SiteSan MarcosTexas92069-

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