Status:
COMPLETED
Comparative Effects of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes
Lead Sponsor:
Bassett Healthcare
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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...
Detailed Description
Specific Aims 1. What is the purpose of this study? What question is it designed to answer? To compare the effect of azithromycin, telithromycin, and levofloxacin on activity of 7 hepatic drug me...
Eligibility Criteria
Inclusion
- Healthy adults between the ages of 18 and 55 years.
- Ability to provide written informed consent.
- Willing to avoid all medications (other than the study drugs) which may inhibit or induce hepatic microsomal enzymes during the study period. This includes prescription and non-prescription medications, vitamins, herbal supplements, and nutriceuticals.
- Willing to avoid drinking more than the equivalence of one beer per day (one 12 ounce beer or equivalent alcohol intake) throughout the study period.
- Women of child-bearing potential who are willing to practice non-hormonal methods of contraception during all study phases.
- Willing to adhere to dietary restrictions as required during the study.
Exclusion
- Clinically significant abnormal findings by history, physical exam, ECG, or laboratory testing.
- Elevated liver function tests twice above the upper limit of the normal range (males AST 0-50 U/L, ALT 0-60 U/L, GGT 11-50; females AST 0-40 U/L, ALT 0-50 U/L, GGT 7-32), or total bilirubin \>1.3mg/dL.
- Baseline INR \>1.2.
- Serum creatinine above the normal ranges
- Women who are pregnant, breastfeeding, and/or not using an acceptable form of non-hormonal contraception (barrier method or abstinence) during the study.
- History of gastrointestinal bleeding or peptic ulcer disease.
- Any condition that may affect drug absorption (e.g., gastrectomy, malabsorption syndromes).
- History of known hypersensitivity or serious adverse reaction to azithromycin, telithromycin, levofloxacin, midazolam, dextromethorphan, caffeine, omeprazole, heparin, warfarin, or vitamin K.
- Poor IV access as determined by an investigator.
- Current illicit drug use.
- History of tobacco use within 3 months of screening.
- Use of any drug known to inhibit or induce hepatic enzymes within 30 days of the first study phase.
- Regular alcohol intake exceeding 1 drink/day (1 drink = 5 ounces of wine or 12 ounces of beer or 1 ounce of hard liquor) within 1 months of screening.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug.
- Presence of any condition that the investigator feels would interfere with successful completion of the study.
- Poor metabolizers of CYP2D6, CYP2C9, and CYP2C19.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00164112
Start Date
November 1 2004
End Date
June 1 2005
Last Update
September 14 2005
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