Drug Metabolism, Poor, CYP2D6-RELATEDPhase 1MalDNCT01289938
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
A Phase 1 study testing Diphenhydramine and Metoclopramide in people with Drug Metabolism, Poor, CYP2D6-RELATED, run by Matthias Schwab at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Metabolism, Poor, CYP2D6-RELATED
- What is being tested?
- Diphenhydramine and Metoclopramide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Jun 2015
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 20 - 27kg/m2
- Caucasians
- Healthy volunteers
Who cannot join
- Pregnancy/lactation period
- Drug allergy
- Acute and chronic diseases
- Taking medication
- Abuse of drugs, alcohol etc.
- Smoker
Trial locations and contacts
1 site in 1 country.
Germany1 site
Abteilung Klinische Pharmakologie, UKT Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6
- Conditions
- Drug Metabolism, Poor, CYP2D6-RELATED
- Being tested
- Diphenhydramine, Metoclopramide
- Keywords
- pharmacokinetic, pharmacogenetic, Metoclopramide, Diphenhydramine, CYP2D6 polymorphisms
- Medical subject headings
- Drug Metabolism, Poor, CYP2D6-Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiphenhydramineDrug
Also called DPH
Diphenhydramine 50 mg oral once
MetoclopramideDrug
Also called MCP
10 mg i.v. metoclopramide once
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Active comparator | Metoclopramide treatment Receives: Drug: Metoclopramide |
| Diphenhydramine | Active comparator | Diphenhydramine treatment Receives: Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
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
Measured: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Secondary outcomes (4)
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
Measured: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
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
Measured: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
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
Measured: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
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
Measured: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startJul 2009
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: To unsuccessful recruitment of rare UM-genotype. All other planned genotype groups are completed (EM, IM and PM).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug Metabolism, Poor, CYP2D6-RELATEDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthias Schwab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthias Schwab, University Hospital Tuebingen
- Investigators
- Matthias Schwab, MD, Principal investigator, UKT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289938
- Sponsor's protocol ID
- IKP231
- Other IDs
- 2008-003778-16, 2008
- Acronym
- MalD
- Status last verified
- May 2016
- First submitted
- 2 Feb 2011
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17113714Schroth 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.
PubMed 18024866