Intrapulmonary Pharmacokinetics of Antibiotics

February 12, 2009 updated by: University of Illinois at Chicago

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters
Time Frame: 7 days
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Sanofi

Investigators

  • Principal Investigator: Keith A. Rodvold, Pharm.D., University of Illinois at Chicago
  • Principal Investigator: Mark H. Gotfried, M.D., Pulmonary Associates, PA
  • Principal Investigator: Larry H. Danziger, Pharm.D., University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

April 14, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (Estimate)

April 18, 2006

Study Record Updates

Last Update Posted (Estimate)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-0748

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Telithromycin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe