Phase 1
N=20
A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01093521 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®) — 503; 537 ug*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 100 mg/m2 dose (Drug); 200 mg/m2 dose (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®) |
503; 537 | — |
| PRIMARY Number of Serious Adverse Events |
— | — |
| PRIMARY Number of Events When Study Drug Infusion Was Stopped Early |
— | — |
| SECONDARY Change in Spirometry From Baseline to Day 8 |
0.13 | — |
| SECONDARY Change in Lung Function From Baseline to Day 15 |
0.13 | — |
| SECONDARY Change in Spirometry From Baseline to Day 28 |
0.10 | — |
| SECONDARY Change in Spirometry From Baseline to Day 56 |
0.12 | — |
| SECONDARY Change in Spirometry as Measured by FVC From Baseline to Day 8 |
0.16 | — |
| SECONDARY Change in P. Aeruginosa Density From Baseline to Day 8 |
21.1 | — |
| SECONDARY Change in Sputum P. Aeruginosa Density From Baseline to Day 15 |
-5.5 | — |
| SECONDARY Change in P. Aeruginosa Density From Baseline to Day 56 |
-76.0 | — |
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)
Eligibility Criteria
Inclusion Criteria
- Adult male or female, between 18 and 55 years of age
- Documented chronic colonization with Pseudomonas Aeruginosa (Pa)
- Confirmed diagnosis of CF:
- Documented history of > 60 mmol/L chloride concentration in pilocarpine sweat chloride test And/Or
- Genotype with two identifiable mutations consistent with CF, accompanied by one or more phenotypic features consistent with diagnosis of CF
- Forced expiratory volume in the first second (FEV1) ≥ 30% of predicted value
- Able to expectorate sputum
- Serum liver function tests ≤ 2.5 x upper limit of normal
- Serum urea nitrogen (BUN) and creatinine ≤ 1.5 x upper limit of normal
- Serum creatinine ≤ 2.0 mg/dl
- Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC) ≥ 4,500/mm3 and ≤ 15,000/mm3
- Ionized calcium ≥ the lower limit of normal
- Able to understand and sign the informed consent document, communicate with the Investigator, and comply with the requirements of the protocol
- If female and of childbearing potential, must have a negative pregnancy test on Day 1 prior to receiving study drug
- 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
- Acute pulmonary exacerbation requiring antibiotic intervention within 2 weeks prior to screening
- Osteoporosis defined as the most recent dexa scan within the prior 5 years with a T-score ≤ -2.5
- Pregnant or lactating female
- Known sensitivity to gallium
- Use of biphosphonates
- Use of any investigational drug and/or participated in any clinical trial within 3 months prior to screening
Data sourced from ClinicalTrials.gov (NCT01093521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.