Intrapulmonary Pharmacokinetics of Antibiotics

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00315601
• Other study ID #: 2005-0748
• Status: Terminated
• Phase: Phase 4
• First received: April 14, 2006
• Last updated: February 12, 2009
• Start date: January 2006
• Est. completion date: November 2006

Study information

• Verified date: February 2009
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Telithromycin
800 mg once a day for 5 days
• 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

Locations

Country	Name	City	State
United States	Pulmonary Associates PA	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters		7 days	No
Secondary	How long does the study antibiotics get into the fluids and cells of the lung.		7 days	No