Intrapulmonary Pharmacokinetics of Antibiotics

Phase 4

Terminated

• Conditions: Healthy

• Registration Number: NCT00315601
• Lead Sponsor: University of Illinois at Chicago

Brief 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.

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-04-14
• Study First Submitted QC: 2006-04-17
• Study First Posted: 2006-04-18
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters	7 days

Secondary Outcome Measures

Name	Time	Method
How long does the study antibiotics get into the fluids and cells of the lung.	7 days

Trial Locations

Locations (1)

Pulmonary Associates PA; 🇺🇸 Phoenix, Arizona, United States