Intrapulmonary Pharmacokinetics of Antibiotics

Stopped early · Phase 4

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00315601

Run by

University of Illinois at Chicago

People needed

35

Starts

2006-01-01

Expected to finish

2006-11-01

Last updated by the study team

2009-02-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pulmonary Associates PA — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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