Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine (MalD)
Primary Purpose
Drug Metabolism, Poor, CYP2D6-RELATED
Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Diphenhydramine
Metoclopramide
Sponsored by
About this trial
This is an interventional basic science trial for Drug Metabolism, Poor, CYP2D6-RELATED focused on measuring pharmacokinetic, pharmacogenetic, Metoclopramide, Diphenhydramine, CYP2D6 polymorphisms
Eligibility 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
Sites / Locations
- Abteilung Klinische Pharmakologie, UKT Tübingen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Metoclopramide
Diphenhydramine
Arm Description
Metoclopramide treatment
Diphenhydramine treatment
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01289938
Brief Title
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Acronym
MalD
Official Title
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
To unsuccessful recruitment of rare UM-genotype. All other planned genotype groups are completed (EM, IM and PM).
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthias Schwab
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Metabolism, Poor, CYP2D6-RELATED
Keywords
pharmacokinetic, pharmacogenetic, Metoclopramide, Diphenhydramine, CYP2D6 polymorphisms
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metoclopramide
Arm Type
Active Comparator
Arm Description
Metoclopramide treatment
Arm Title
Diphenhydramine
Arm Type
Active Comparator
Arm Description
Diphenhydramine treatment
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
DPH
Intervention Description
Diphenhydramine 50 mg oral once
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
MCP
Intervention Description
10 mg i.v. metoclopramide once
Primary Outcome Measure Information:
Title
Area under curve of metoclopramide (MCP)
Description
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
Time Frame
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Title
Area under curve of diphenhydramine(DPH)
Description
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
Time Frame
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Secondary Outcome Measure Information:
Title
Cmax of metoclopramide
Description
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
Time Frame
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Title
Tmax of metoclopramide
Description
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
Time Frame
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Title
Cmax of diphenhydramine
Description
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
Time Frame
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Title
Tmax of diphenhydramine
Description
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
Time Frame
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Schwab, MD
Organizational Affiliation
UKT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abteilung Klinische Pharmakologie, UKT Tübingen
City
Tübingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17113714
Citation
Kirchheiner J, Seeringer A. Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes. Biochim Biophys Acta. 2007 Mar;1770(3):489-94. doi: 10.1016/j.bbagen.2006.09.019. Epub 2006 Oct 4.
Results Reference
background
PubMed Identifier
18024866
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. doi: 10.1200/JCO.2007.12.2705.
Results Reference
background
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Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
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