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Tracking Information | |||||
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First Received Date † | September 9, 2005 | ||||
Last Updated Date | September 13, 2005 | ||||
Start Date † | November 2004 | ||||
Current Primary Outcome Measures † |
Phenotype measures | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00164112 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Comparative Effects of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes | ||||
Official Title † | Comparison of the Effect of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes Using the Validated Cooperstown 5+1 Cocktail | ||||
Brief Summary | Studies have previously shown that a broad drug interaction screening can be performed using enzyme specific probes such as oral caffeine for CYP1A2, N-acetyltrasferase-2 (NAT-2), and xanthine oxidase (XO), warfarin plus vitamin K for CYP2C9, omeprazole for CYP 2C19, dextromethorphan for CYP2D6, and midazolam for CYP3A4/5. This combination of probes has been validated in the Cooperstown 5+1 Cocktail (5+1).1 The use of the 5+1 cocktail provides information on the drug metabolizing enzymes that metabolize 90% of hepatically eliminated drugs for a fraction of the costs of the individual studies. Using a cocktail of biomarkers reduces the overall cost of drug interaction screening. The purpose of this study is to evaluate the effects of three Food and Drug Administration (FDA) approved oral antibiotics (azithromycin, telithromycin, and levofloxacin) on metabolism of other medications when taken together. This will be determined by the measuring the activity of drug metabolizing enzymes following administration of certain drug probes (caffeine, dextromethorphan, omeprazole, midazolam, and warfarin with vitamin K). A total of 16 subjects will complete four phases of the study: 1) Cooperstown 5+1 alone, 2) Azithromycin plus Cooperstown 5+1, 3) Telithromycin plus Cooperstown 5+1, and 4) Levofloxacin plus Cooperstown 5+1. |
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Detailed Description | Specific Aims
Prior to any procedure of the study each subject will provide written informed consent. All the subjects will be genotyped for CYP2D6, CYP2C9, and CYP2C19 after obtaining informed consent for pharmacogenomics. This is to distinguish poor metabolizers from extensive metabolizers. Prestudy screening will be conducted within 4 weeks of the first study phase. Subjects will undergo a complete medical history, social history (including medication, alcohol, and tobacco use), physical examination, standard 12-lead electrocardiogram (ECG), and laboratory screening to assure that inclusion and exclusion criteria are met. The laboratory screening data to be obtained are: complete blood count, prothrombin time (PT), international normalized ratio (INR), macroscopic and microscopic urinalysis, electrolytes, blood urea nitrogen (BUN), serum creatinine, aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin, and serum albumin. Women of childbearing potential (defined as premenopausal with no history of hysterectomy or tubal ligation) will undergo a serum pregnancy test during the screening visit and a urine pregnancy test prior to each phase of the study. Following enrollment, subjects will participate in each of the 4 study phases in a random order. Study Design and Procedures This will be a randomized, crossover, open-label study. Prestudy screening will be conducted within 4 weeks of the first study phase. Screening visits will involve obtaining informed consent, medical history, social history, physical examination, ECG, and laboratory tests. Following enrollment, subjects will be randomized (and then crossed over) to 4 phases as described in Table 1. Table 1. Study Design Study Drugs and Procedure Phase 1 (control) Cooperstown 5+1 Cocktail alone. The Cooperstown 5+1 Cocktail consists of the following components:
4) If the research is in part a treatment protocol, identify which parts are routine and which parts are being done solely for research. This study is for research purposes. |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Diagnostic, Randomized, Open Label, Placebo Control, Crossover Assignment, Pharmacokinetics Study | ||||
Condition † | Healthy | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 16 | ||||
Completion Date | June 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00164112 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Bassett Healthcare | ||||
Collaborators †† | PriCara, Unit of Ortho-McNeil, Inc. | ||||
Investigators † |
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Information Provided By | Bassett Healthcare | ||||
Verification Date | March 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |