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NCT03329001 · ClinicalTrials.gov registry record · Phase 1
Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
A Phase 1 study of Neoplasms, sponsored by Tesaro.
- Completed
- Registry status
- Phase 1
- Development phase
- 236
- Enrollment target
- 16
- Study locations
NCT03329001 is a Phase 1 study of Neoplasms that has completed, run by Tesaro. The registered enrollment target is 236 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (85% lower). The trial reports 16 study locations across 11 states.
The verdict
NCT03329001, a Phase 1 study of Neoplasms, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 236 participants
- Enrollment target
- 16
- Study locations
Study 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 Studied
Interventions
- DRUG Niraparib Tablet
- DRUG Niraparib Capsule
Study Locations (16)
Texas
- GSK Investigational Site - Dallas
- GSK Investigational Site - Houston
- GSK Investigational Site - San Antonio
- GSK Investigational Site - San Marcos
California
- GSK Investigational Site - Encinitas
- GSK Investigational Site - Fresno
Ohio
- GSK Investigational Site - Cincinnati
- GSK Investigational Site - Cleveland
Colorado
- GSK Investigational Site - Denver
Connecticut
- GSK Investigational Site - New Haven
Florida
- GSK Investigational Site - Sarasota
Georgia
- GSK Investigational Site - Atlanta
Michigan
- GSK Investigational Site - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2023-06-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03329001
The ClinicalTrials.gov registry entry for NCT03329001 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (85% lower). The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Niraparib Tablet is the first listed.
NCT03329001 reports 16 study locations spanning 11 distinct geographic areas - top geographies include Texas, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT03329001 about?
NCT03329001 is a clinical study titled "Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule". 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 ...
What is the current status of trial NCT03329001?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 236 participants. The study started on 2017-12-04. Estimated completion is 2023-06-15.
What conditions does trial NCT03329001 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT03329001?
The interventions under investigation include: Niraparib Tablet (DRUG), Niraparib Capsule (DRUG).
Who is sponsoring clinical trial NCT03329001?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03329001 being conducted?
This trial has 16 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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