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Sponsors and Collaborators: |
Bassett Healthcare PriCara, Unit of Ortho-McNeil, Inc. |
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Information provided by: | Bassett Healthcare |
ClinicalTrials.gov Identifier: | NCT00164112 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: Cooperstown 5+1 alone Drug: Azithromycin plus Cooperstown 5+1 Drug: Telithromycin plus Cooperstown 5+1 Drug: Levofloxacin plus Cooperstown 5+1 |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Placebo Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Comparison of the Effect of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes Using the Validated Cooperstown 5+1 Cocktail |
Estimated Enrollment: | 16 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | June 2005 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CAPSS-273 |
Study First Received: | September 9, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00164112 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cooperstown Cocktail Drug Metabolizing Enzymes Drug Interactions Phenotyping |
Anti-Infective Agents Anti-Bacterial Agents Azithromycin Ofloxacin |
Anti-Infective Agents, Urinary Healthy Telithromycin |
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Azithromycin Ofloxacin |
Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Telithromycin |