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Intrapulmonary Pharmacokinetics of Antibiotics
This study has been terminated.
(Sanofi-Aventis wanted the study terminated.)
Sponsor:
University of Illinois at Chicago
Collaborator:
Sanofi
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00315601
First received: April 14, 2006
Last updated: February 12, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Healthy | Drug: Telithromycin Drug: azithromycin Procedure: bronchoalveolar lavage | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects |
Resource links provided by NLM:
Further study details as provided by University of Illinois at Chicago:
Primary Outcome Measures:
- Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters [ Time Frame: 7 days ]
Secondary Outcome Measures:
- How long does the study antibiotics get into the fluids and cells of the lung. [ Time Frame: 7 days ]
| Enrollment: | 35 |
| Study Start Date: | January 2006 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Telithromycin
800 mg once a day for 5 days
Other Name: Ketek
Drug: azithromycin
500 mg on day 1, and then 250 mg once-daily on days 2 through 5
Other Name: Zithromax
Procedure: bronchoalveolar lavage
One bronchoscopy with bronchoalveolar lavage with each drug administration
Other Name: Bronchoscopy with BAL
Drug: Telithromycin
Telithromycin 800 mg once a day
Other Name: Ketek
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315601
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315601
Locations
| United States, Arizona | |
| Pulmonary Associates PA | |
| Phoenix, Arizona, United States, 85006 | |
Sponsors and Collaborators
University of Illinois at Chicago
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 |
More Information
| Responsible Party: | University of Illinois at Chicago |
| ClinicalTrials.gov Identifier: | NCT00315601 History of Changes |
| Other Study ID Numbers: |
2005-0748 |
| Study First Received: | April 14, 2006 |
| Last Updated: | February 12, 2009 |
Keywords provided by University of Illinois at Chicago:
|
Telithromycin (drug) Azithromycin (drug) Bronchoalveolar lavage (procedure) Pharmacokinetics |
Additional relevant MeSH terms:
|
Telithromycin Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on July 19, 2017