MalD: Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

• Sponsor: Matthias Schwab (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01289938
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Duration (Months): 71
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Drug Metabolism, Poor, CYP2D6-RELATED	Drug: Diphenhydramine; Drug: Metoclopramide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Metoclopramide Metoclopramide treatment	Drug: Metoclopramide; 10 mg i.v. metoclopramide once; Other Names: MCP
Active Comparator: Diphenhydramine Diphenhydramine treatment	Drug: Diphenhydramine; Diphenhydramine 50 mg oral once; Other Names: DPH

Outcome Measures

Primary Outcome Measures

1. Area under curve of metoclopramide (MCP) [0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours]

   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

2. Area under curve of diphenhydramine(DPH) [0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours]

   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

Secondary Outcome Measures

1. Cmax of metoclopramide [0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours]

   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

2. Tmax of metoclopramide [0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours]

   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

3. Cmax of diphenhydramine [0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours]

   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

4. Tmax of diphenhydramine [0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abteilung Klinische Pharmakologie, UKT Tübingen	Tübingen	BW	Germany	72076

Sponsors and Collaborators

• Matthias Schwab

Investigators

• Principal Investigator: Matthias Schwab, MD, UKT

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Matthias Schwab, Prof. M.D., University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT01289938
• Other Study ID Numbers: IKP231; 2008-003778-16
• First Posted: Feb 4, 2011
• Last Update Posted: May 13, 2016
• Last Verified: May 1, 2016

• Keywords provided by Matthias Schwab, Prof. M.D., University Hospital Tuebingen: pharmacokinetic; pharmacogenetic; Metoclopramide; Diphenhydramine; CYP2D6 polymorphisms
• Additional relevant MeSH terms: Metabolism, Inborn Errors; Diphenhydramine; Promethazine; Metoclopramide

Study Results

No Results Posted as of May 13, 2016