Intrapulmonary Pharmacokinetics of Antibiotics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Telithromycin
* Drug: azithromycin
* Procedure: bronchoalveolar lavage
* Drug: Telithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Telithromycin|800 mg once a day for 5 days|
|Drug: azithromycin|500 mg on day 1, and then 250 mg once-daily on days 2 through 5|
|Procedure: bronchoalveolar lavage|One bronchoscopy with bronchoalveolar lavage with each drug administration|
|Drug: Telithromycin|Telithromycin 800 mg once a day|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How long does the study antibiotics get into the fluids and cells of the lung. |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telithromycin (drug), Azithromycin (drug), Bronchoalveolar lavage (procedure), Pharmacokinetics