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

NCT02515526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-09-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Umm Al-Qura University

    collaborator OTHER

  • University of Cologne

    lead OTHER

Principal Investigators

  • Uwe Fuhr · Department of Pharmacology,University Hospital Cologne

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-08-27
Completion
2015-08-27

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515526 on ClinicalTrials.gov