drugset / Trial / NCT01093521
A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
Non-randomizedSingle-groupOpen-labelOther
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)
Timeline
- Start
- 2010-04
- Primary completion
- 2012-04
- Completion
- 2013-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | gallium nitrate | Small molecule | 100 mg/m2 | Intravenous |
| Subject | gallium nitrate | Small molecule | 200 mg/m2 | Intravenous |