Intrapulmonary Pharmacokinetics of Antibiotics

Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects

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.

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.

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