Intrapulmonary Pharmacokinetics of Antibiotics

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00315601

Enrollment

Registered

2006-04-18

Start date

2006-01-31

Completion date

2006-11-30

Last updated

2009-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Telithromycin (drug), Azithromycin (drug), Bronchoalveolar lavage (procedure), Pharmacokinetics

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.

Interventions

DRUGTelithromycin

800 mg once a day for 5 days

DRUGazithromycin

500 mg on day 1, and then 250 mg once-daily on days 2 through 5

PROCEDUREbronchoalveolar lavage

One bronchoscopy with bronchoalveolar lavage with each drug administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters	7 days

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026