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Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
NCT03329001 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03329001 reports 16 study locations spanning 11 distinct geographic areas — top geographies include Texas, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03329001?
The interventions under investigation include: Niraparib Tablet (DRUG), Niraparib Capsule (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03329001?
This trial is sponsored by Tesaro, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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