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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
- ClinicalTrials.gov ID
- NCT01289938
- Acronym / sponsor ID
- MalD / IKP231
- Conditions
- Drug Metabolism, Poor, CYP2D6-RELATED
- Keywords
- pharmacokinetic, pharmacogenetic, Metoclopramide, Diphenhydramine, CYP2D6 polymorphisms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To unsuccessful recruitment of rare UM-genotype. All other planned genotype groups are completed (EM, IM and PM).
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Matthias SchwabUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Active comparator | Drug: MetoclopramideMetoclopramide treatment |
| Diphenhydramine | Active comparator | Drug: DiphenhydramineDiphenhydramine treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 20 - 27kg/m2
- Caucasians
- Healthy volunteers
Key exclusion criteria (6 listed)
- Pregnancy/lactation period
- Drug allergy
- Acute and chronic diseases
- Taking medication
- Abuse of drugs, alcohol etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiphenhydramineAlso: DPHDiphenhydramine 50 mg oral once | Drug | Diphenhydramine |
| MetoclopramideAlso: MCP10 mg i.v. metoclopramide once | Drug | Metoclopramide |
Primary outcome
Area under curve of metoclopramide (MCP)
Time frame: 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
Area under curve of diphenhydramine(DPH)
Time frame: 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
4 secondary outcomes
Cmax of metoclopramide
Time frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Tmax of metoclopramide
Time frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Cmax of diphenhydramine
Time frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Tmax of diphenhydramine
Time frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Results and safety
The study was stopped early (reason given: To unsuccessful recruitment of rare UM-genotype. All other planned genotype groups are completed (EM, IM and PM).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 17113714Kirchheiner 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.
- Background: PubMed 18024866Schroth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Schwab, MD principal investigator
UKT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: To unsuccessful recruitment of rare UM-genotype. All other planned genotype groups are completed (EM, IM and PM).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve of metoclopramide (MCP) (time frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01289938, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.