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

NCT03329001 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2024-07-25

Study results available
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Summary

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.

Conditions

  • Neoplasms

Interventions

DRUG

Niraparib Tablet

Niraparib tablet formulation

DRUG

Niraparib Capsule

Niraparib capsule formulation

Sponsors & Collaborators

  • Tesaro, Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2021-12-30
Completion
2023-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329001 on ClinicalTrials.gov