A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Surgery

Official Title: “A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin in Serum, Bronchial Washings and Lung Tissue Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Resection”

The objective of this trial was to characterize the pharmacokinetics of the currently marketed azithromycin immediate release tablet formulation (AZ-IR) versus the azithromycin sustained release liquid formulation (AZ-SR) in lung tissue and bronchial washings, the latter consisting of the epithelial lining fluid (ELF) and cellular elements, mainly alveolar macrophages (AM).

Intervention(s) in this Clinical Trial

• Drug: azithromycin immediate release (Zithromax)
  • azithromycin IR 500 mg tablet by mouth for 1 dose
• Other: placebo
  • placebo
• Drug: azithromycin SR
  • 2.0 g by mouth in the form of liquid for 1 dose
• Other: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum
  • Time Frame: predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
    Safety Issue?: No
• Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples
  • Time Frame: 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
    Safety Issue?: No

Secondary Measures

• 12-lead electrocardiograms (ECGs)
  • Time Frame: Screening and 72 hours postdose
    Safety Issue?: Yes
• adverse events (AEs)
  • Time Frame: Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
    Safety Issue?: Yes
• safety laboratory tests
  • Time Frame: Treatment day 0 and 72 hours postdose
    Safety Issue?: Yes
• vital signs
  • Time Frame: Screening and Treatment day 0
    Safety Issue?: Yes

Inclusion Criteria:

• Inclusion criteria were hospitalized subjects diagnosed with lung cancer that had consented to surgery requiring lung resection who had a life expectancy of >6 months.

Exclusion Criteria:

• Key exclusion criteria were antibiotic prophylaxis prior to surgery, diffuse, non-infectious lung disease, history of cigarette smoking of >5 packs per year, patients with any infectious disease that required antibiotic therapy, administration of drugs known to interfere with azithromycin pharmacokinetics, and subjects on chemotherapy.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644176

Study ID Number: A0661145

ClinicalTrials.gov Identifier: NCT00644176

Health Authority: United States: Food and Drug Administration

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