Intrapulmonary Pharmacokinetics of Antibiotics

• Status: Terminated
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborator: Sanofi
• Treatments: Azithromycin; Telithromycin

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