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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01093521
• Date of registration: 24/03/2010
• Prospective Registration: Yes
• Primary sponsor: University of Washington
• Public title: A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
• Scientific title: A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
• Date of first enrolment: April 2010
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01093521
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Christopher H Goss, MD, MSc
• Affiliation: University of Washington

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: 200 mg/m2 dose

Drug: 100 mg/m2 dose

Primary Outcome(s)

Number of Events When Study Drug Infusion Was Stopped Early [Time Frame: 6 days from starting dose]

Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®) [Time Frame: Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28]

Number of Serious Adverse Events [Time Frame: 56 days from starting dose]

Secondary Outcome(s)

Change in Lung Function From Baseline to Day 15 [Time Frame: 15 days from starting dose]

Change in Spirometry as Measured by FVC From Baseline to Day 8 [Time Frame: 8 days from starting dose]

Change in P. Aeruginosa Density From Baseline to Day 56 [Time Frame: 56 days from starting dose]

Change in Spirometry From Baseline to Day 8 [Time Frame: 8 days]

Change in P. Aeruginosa Density From Baseline to Day 8 [Time Frame: 8 days from starting dose]

Change in Spirometry From Baseline to Day 28 [Time Frame: 28 days from starting dose]

Change in Spirometry From Baseline to Day 56 [Time Frame: 56 days from starting dose]

Change in Sputum P. Aeruginosa Density From Baseline to Day 15 [Time Frame: 15 days from starting dose]

Secondary ID(s)

35876

US FDA 5R01FD003704

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation

Results

• Results available: Yes
• Date Posted: 12/01/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01093521