Intrapulmonary Pharmacokinetics of Antibiotics

Phase 4TerminatedNCT00315601

University of Illinois at Chicago35 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

TelithromycinDRUG

800 mg once a day for 5 days

azithromycinDRUG

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

bronchoalveolar lavagePROCEDURE

One bronchoscopy with bronchoalveolar lavage with each drug administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pulmonary Associates PA

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters

Time frame: 7 days

Secondary Outcomes

How long does the study antibiotics get into the fluids and cells of the lung.

Time frame: 7 days

Data from ClinicalTrials.gov

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