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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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 facts

Study ID

NCT03329001

Run by

Tesaro, Inc.

People needed

236

Starts

2017-12-04

Expected to finish

2023-06-15

Last updated by the study team

2024-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• GSK Investigational Site — Encinitas, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — New Haven, Connecticut, United States
• GSK Investigational Site — Sarasota, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Grand Rapids, Michigan, United States
• GSK Investigational Site — Jackson, Mississippi, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — San Marcos, Texas, United States

Full record on ClinicalTrials.gov

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