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

• Status: Completed
• Trial end date: 2013-08-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Gallium nitrate

Criteria

Inclusion Criteria:

1. Adult male or female, between 18 and 55 years of age

2. Documented chronic colonization with Pseudomonas Aeruginosa (Pa)

3. Confirmed diagnosis of CF:

1. Documented history of > 60 mmol/L chloride concentration in pilocarpine sweat chloride test And/Or

2. Genotype with two identifiable mutations consistent with CF, accompanied by one or more phenotypic features consistent with diagnosis of CF

4. Forced expiratory volume in the first second (FEV1) ≥ 30% of predicted value

5. Able to expectorate sputum

6. Serum liver function tests ≤ 2.5 x upper limit of normal

7. Serum urea nitrogen (BUN) and creatinine ≤ 1.5 x upper limit of normal

8. Serum creatinine ≤ 2.0 mg/dl

9. Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC) ≥ 4,500/mm3 and ≤ 15,000/mm3

10. Ionized calcium ≥ the lower limit of normal

11. Able to understand and sign the informed consent document, communicate with the Investigator, and comply with the requirements of the protocol

12. If female and of childbearing potential, must have a negative pregnancy test on Day 1 prior to receiving study drug

13. If female and of childbearing potential, is willing to use adequate contraception, as determined by the investigator, for the duration of the study

Exclusion Criteria:

1. Acute pulmonary exacerbation requiring antibiotic intervention within 2 weeks prior to screening

2. Osteoporosis defined as the most recent dexa scan within the prior 5 years with a T-score ≤ -2.5

3. Pregnant or lactating female

4. Known sensitivity to gallium

5. Use of biphosphonates

6. Use of any investigational drug and/or participated in any clinical trial within 3 months prior to screening