Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

Condition(s) targeted: Drug Metabolism, Poor, CYP2D6-RELATED

Intervention: Diphenhydramine (Drug); Metoclopramide (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Matthias Schwab

Official(s) and/or principal investigator(s):
Matthias Schwab, MD, Principal Investigator, Affiliation: UKT

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

Official title: Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

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

Primary outcome:

Area under curve of metoclopramide (MCP)

Area under curve of diphenhydramine(DPH)

Secondary outcome:

Cmax of metoclopramide

Tmax of metoclopramide

Cmax of diphenhydramine

Tmax of diphenhydramine

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Abteilung Klinische Pharmakologie, UKT Tübingen, Tübingen, BW 72076, Germany

Related publications:

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.

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.

Starting date: July 2009
Last updated: May 26, 2015