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NCT03359850 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients
A Phase 1 study, sponsored by Tesaro.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT03359850 is a Phase 1 study that has completed, run by Tesaro. The registered enrollment target is 17 participants.
The verdict
NCT03359850, a Phase 1 study, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment, for the purpose of providing recommendations to guide the initial dose and dose titration in this patient population.
Interventions
- DRUG Niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2020-06-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03359850
The ClinicalTrials.gov registry entry for NCT03359850 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Niraparib is the first listed.
NCT03359850 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03359850 about?
NCT03359850 is a clinical study titled "Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients". Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment, for the purpose of providing recommendations to guide the initial dose...
What is the current status of trial NCT03359850?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2018-02-20. Estimated completion is 2020-06-24.
What interventions are being tested in trial NCT03359850?
The interventions under investigation include: Niraparib (DRUG).
Who is sponsoring clinical trial NCT03359850?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
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