Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

Drug Metabolism, Poor, CYP2D6-RELATED Clinical Trial

— MalD  

Official title:

Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01289938
• Other study ID #: IKP231
• Secondary ID: 2008-003778-16
• Status: Terminated
• Phase: Phase 1
• First received: February 2, 2011
• Last updated: May 12, 2016
• Start date: July 2009
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI 20 - 27kg/m2

• Caucasians

• Healthy volunteers

Exclusion Criteria:

• Pregnancy/lactation period

• Drug allergy

• Acute and chronic diseases

• Taking medication

• Abuse of drugs, alcohol etc.

• Smoker

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Drug Metabolism, Poor, CYP2D6-RELATED
• Metabolism, Inborn Errors

Intervention

Drug:
• Diphenhydramine
Diphenhydramine 50 mg oral once
• Metoclopramide
10 mg i.v. metoclopramide once

Locations

Country	Name	City	State
Germany	Abteilung Klinische Pharmakologie, UKT Tübingen	Tübingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
Matthias Schwab

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Kirchheiner J, Seeringer A. Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes. Biochim Biophys Acta. 2007 Mar;1770(3):489-94. Epub 2006 Oct 4. Review. — View Citation

Schroth W, Antoniadou L, Fritz P, Schwab M, Muerdter T, Zanger UM, Simon W, Eichelbaum M, Brauch H. Breast cancer treatment outcome with adjuvant tamoxifen relative to patient CYP2D6 and CYP2C19 genotypes. J Clin Oncol. 2007 Nov 20;25(33):5187-93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve of metoclopramide (MCP)	Pharmacokinetic of MCP at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	No
Primary	Area under curve of diphenhydramine(DPH)	Pharmacokinetics of DPH at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	No
Secondary	Cmax of metoclopramide	Cmax of metoclopramide at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	No
Secondary	Tmax of metoclopramide	Tmax of metoclopramide at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	No
Secondary	Cmax of diphenhydramine	Cmax of diphenhydramine at the following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	No
Secondary	Tmax of diphenhydramine	Tmax of diphenhydramine at the following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	No