drugset / Trial / NCT01093521

A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients

NCT01093521

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

EvaluationDrugModalityDoseRoute
Subject gallium nitrate Small molecule 100 mg/m2 Intravenous
Subject gallium nitrate Small molecule 200 mg/m2 Intravenous

Indications