Intrapulmonary Pharmacokinetics of Antibiotics

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University of Illinois Sanofi-Aventis
Information provided by:	University of Illinois
ClinicalTrials.gov Identifier:	NCT00315601

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 IV

MedlinePlus related topics: Antibiotics

Drug Information available for: Azithromycin Telithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Official Title:	Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects

Further study details as provided by University of Illinois:

Estimated Enrollment:	35
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2006

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
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

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

Sanofi-Aventis

Investigators

Principal Investigator:	Keith A. Rodvold, Pharm.D.	University of Illinois
Principal Investigator:	Mark H. Gotfried, M.D.	Pulmonary Associates PA
Principal Investigator:	Larry H. Danziger, Pharm.D.	University of Illinois

More Information

Study ID Numbers:	2005-0748
Study First Received:	April 14, 2006
Last Updated:	August 28, 2006
ClinicalTrials.gov Identifier:	NCT00315601
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Illinois:

Telithromycin (drug)
Azithromycin (drug)
Bronchoalveolar lavage (procedure)
Pharmacokinetics

Study placed in the following topic categories:

Azithromycin
Healthy
Telithromycin

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009