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| Sponsor: | Indiana University School of Medicine |
|---|---|
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00318201 |
Purpose
We, the researchers at the Indiana University School of Medicine, are doing this study to better understand how the effects of certain medications are altered when taken simultaneously, or in combination with each other. We will also look at how each volunteer's genes (DNA) may affect the way these medications are metabolized.
Hypothesis:
We will test the hypothesis that the extent of drug-drug interaction caused by the combination of erythromycin and diltiazem is not predictable from the extent of interaction produced by each inhibitor alone. Specifically we will test the hypothesis that the combination of erythromycin and diltiazem will cause a greater decrease in midazolam intravenous and oral clearance than the sum of the decreases caused by each inhibitor alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Erythromycin Drug: Diltiazem |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers |
| Enrollment: | 7 |
| Study Start Date: | April 2006 |
| Study Completion Date: | December 2007 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Altered efficacy for drug to drug interaction of diltiazam with erythromycin
|
Drug: Erythromycin Drug: Diltiazem |
Many drugs such as diltiazem are metabolized by CYP3A4, the cytochrome P450 enzyme responsible for the metabolism of erythromycin and when given together, the possibility exists that one drug inhibits the metabolism of the other leading to an increase in plasma concentration. The magnitude of this interaction is not known. It is therefore important to define this effect because diltiazem is a drug that is used commonly to treat hypertension, angina and atrial fibrillation and these patients may be given erythromycin for the treatment of intercurrent bacterial infections.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Approximately 45 healthy volunteers may be recruited to participate in the study, with a goal of 15 healthy volunteers (7 or 8 males) completing the entire four phases. All potential subjects:
Exclusion Criteria:
Potential volunteers will be excluded:
If they have allergies or are hypersensitive to any of the study medications:
A. Midazolam (Versed) or related benzodiazepines drugs such as diazepam (Valium) or alprazolam (Xanax).
B. Diltiazem (Cardizem, Dilacor) or related calcium channel blockers such as verapamil (Calan, Isoptin).
C. Erythromycin (Erythrocin, E-mycin, Ery-tab) or related antibiotics such as clarithromycin (Biaxin) or have experienced abdominal pain when taking erythromycin or other related medications.
Contacts and Locations| United States, Indiana | |
| Indiana University Medical Center / GCRC | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | Stephen D Hall, PhD | Indiana University |
More Information
| Responsible Party: | Indiana University ( Stephen D. Hall ) |
| Study ID Numbers: | # 0412-09, R01GM067308/NIGMS, MO1RR000750/GCRC #1267 |
| Study First Received: | April 21, 2006 |
| Last Updated: | December 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00318201 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Healthy Subjects |
|
Erythromycin stearate Anti-Infective Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Erythromycin Ethylsuccinate Gastrointestinal Agents Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Erythromycin |
Antihypertensive Agents Pharmacologic Actions Membrane Transport Modulators Anti-Bacterial Agents Protein Synthesis Inhibitors Verapamil Erythromycin Estolate Therapeutic Uses Diltiazem Anti-Arrhythmia Agents |