NCT00318201

The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Erythromycin
DRUG	Diltiazem

Timeline

• Start date: 2006-04-01
• Completion: 2007-12-01
• First posted: 2006-04-26
• Last updated: 2012-04-06

Locations

1 site across 1 country: United States