NCT03329001

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

An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Niraparib Tablet	Niraparib tablet formulation
DRUG	Niraparib Capsule	Niraparib capsule formulation

Timeline

• Start date: 2017-12-04
• Primary completion: 2021-12-30
• Completion: 2023-06-15
• First posted: 2017-11-01
• Last updated: 2024-07-25
• Results posted: 2024-04-26

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study