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NCT01093521 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01093521 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 20 participants.
The verdict
NCT01093521, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the pharmacokinetics, safety, and tolerability of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the drug are found in the sputum. Funding Source - Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD)
Interventions
- DRUG 100 mg/m2 dose
- DRUG 200 mg/m2 dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-08-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01093521
The ClinicalTrials.gov registry entry for NCT01093521 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 100 mg/m2 dose is the first listed.
NCT01093521 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01093521 about?
NCT01093521 is a clinical study titled "A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients". The purpose of this research study is to test the pharmacokinetics, safety, and tolerability of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the drug are found in the sp...
What is the current status of trial NCT01093521?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-04. Estimated completion is 2013-08-31.
What interventions are being tested in trial NCT01093521?
The interventions under investigation include: 100 mg/m2 dose (DRUG), 200 mg/m2 dose (DRUG).
Who is sponsoring clinical trial NCT01093521?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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