NCT02515526

Effect of Acute Ethanol Consumption on The Activity of Major Cytochrome P450 Enzymes, NAT2 and P-glycoprotein

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Protocol title: Effect of acute alcohol consumption on the activity of major cytochrome P450 enzymes, NAT2 and P-glycoprotein. Objectives: The study is mainly conducted to evaluate the effect of acute alcohol consumption on the activity of the most important drug metabolising cytochrome P450 enzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, intestinal CYP3A4, hepatic CYP3A4, NAT2 and on the activity of the drug transporter p-glycoprotein (intestinal and renal). The study should also provide basis for a planned clinical study on interactions caused by chronic alcohol intake. Design: Single center, open-label, two-way, cross-over study with randomly allocated sequences Test-Reference or Reference-Test. The study is not a clinical drug study according to the German Drug Act. Clinical phase: Not applicable Volunteers: 16 healthy male and female subjects are planned for completion in accordance with the protocol, i.e. with evaluable/analysable data for all periods and treatments. Clinical centre: Department of Pharmacology, Clinical Pharmacology Unit (KPH), University of Cologne, Gleueler Str. 24, 50931Köln, Germany

Conditions

• AOD Effects and Consequences

Interventions

Type	Name	Description
DRUG	caffeine, tolbutamide, omeprazole, dextromethorphan, digoxin, midazolam single doses	Reference period
DRUG	ethanol multiple doses plus caffeine, tolbutamide, omeprazole, dextromethorphan, digoxin, midazolam single doses	Test period

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-08-27
• Completion: 2015-08-27
• First posted: 2015-08-04
• Last updated: 2019-09-09

Locations

1 site across 1 country: Germany