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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: Completed Phase 1 study, sponsored by Tesaro.
NCT03359850 is a Phase 1 study that has completed, run by Tesaro. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples were collected at indicated time points to evaluate AUC (last) of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Interventions
- DRUG Niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2020-06-24 |
| Phase | Phase 1 |
What the finished NCT03359850 record still lists
NCT03359850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Niraparib is the first listed.
NCT03359850 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03359850's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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