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Intrapulmonary Pharmacokinetics of Antibiotics

This study has been terminated.
(Sanofi-Aventis wanted the study terminated.)
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00315601
First received: April 14, 2006
Last updated: February 12, 2009
Last verified: February 2009
History of Changes
  Purpose
The major objectives of this research are to see how much, and for how long, telithromycin and azithromycin get into the fluids and cells of the lung.

Condition Intervention Phase
Healthy
 Drug: Telithromycin
Drug: azithromycin
Procedure: bronchoalveolar lavage
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • How long does the study antibiotics get into the fluids and cells of the lung. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Enrollment: 35
Study Start Date: January 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Telithromycin
    800 mg once a day for 5 days
    Other Name: Ketek
    Drug: azithromycin
    500 mg on day 1, and then 250 mg once-daily on days 2 through 5
    Other Name: Zithromax
    Procedure: bronchoalveolar lavage
    One bronchoscopy with bronchoalveolar lavage with each drug administration
    Other Name: Bronchoscopy with BAL
    Drug: Telithromycin
    Telithromycin 800 mg once a day
    Other Name: Ketek
Detailed Description:
The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM) concentrations following multiple oral doses of telithromycin and azithromycin in healthy, non-smoking adult subjects.
  Eligibility
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 18 and 55 years, inclusive, of age
  • No history of smoking within the last 1 year
  • Body weight within +/- 15% of the Metropolitan Life Insurance Company tables
  • No clinically important abnormalities in the medical history or physical exam
  • Female subjects of childbearing potential must have a negative pregnancy test
  • Female subjects of childbearing potential must use reliable methods of birth control

Exclusion Criteria:

  • Allergy to telithromycin, azithromycin, or any macrolide antibiotic
  • Allergy or serious adverse reactions to benzodiazepines or lidocaine
  • History of renal, gastrointestinal, or liver disease
  • Significant hypertension
  • Clinically significant heart or pulmonary diseases
  • History of drug or alcohol dependence within 12 months of study entry
  • Positive pregnancy test
  • Currently breast feeding
  • Use of any drug within 2 weeks of study entry
  • Received an investigational drug within 30 days of study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315601

Locations
United States, Arizona
Pulmonary Associates PA
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
University of Illinois at Chicago
Sanofi
Investigators
Principal Investigator: Keith A. Rodvold, Pharm.D. University of Illinois at Chicago
Principal Investigator: Mark H. Gotfried, M.D. Pulmonary Associates, PA
Principal Investigator: Larry H. Danziger, Pharm.D. University of Illinois at Chicago
  More Information

Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00315601     History of Changes
Other Study ID Numbers: 2005-0748 
Study First Received: April 14, 2006
Last Updated: February 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Telithromycin (drug)
Azithromycin (drug)
Bronchoalveolar lavage (procedure)
Pharmacokinetics

Additional relevant MeSH terms:
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 26, 2016