Carboxylesterase 1 (CES1) GenotypePhase 4NCT02147535
Impact of CES1 Genotype on Metabolism of Methylphenidate
A Phase 4 study testing Methylphenidate in people with Carboxylesterase 1 (CES1) Genotype and CES1 Activity, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of methylphenidate, a CES1 dependent drug. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Carboxylesterase 1 (CES1) Genotype, CES1 Activity
- What is being tested?
- Methylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Aug 2014
- Phase
- Phase 4
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- > 18 years old
- Caucasian
Who cannot join
- Chronic disease (except hay fever and eczema)
- Pregnancy
- Smoking
- High level of alcohol consumption (> 21 units per week for men and 14 for women)
- Known allergy towards methylphenidate
- Permanent use of medication (contraception ok)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Pharmacology, Bispebjerg University Hospital
Copenhagen, 2400
About this study
The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of methylphenidate, a CES1 dependent drug.
- Conditions
- Carboxylesterase 1 (CES1) Genotype, CES1 Activity
- Being tested
- Methylphenidate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
10 mg as a single dose followed by one blood sample 3 hours post-dose
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | Not described Receives: Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of methylphenidate and ritalinic acid
We are looking at the ratio of methylphenidate to ritalinic acid (metabolite) 3 hours post-dose as a measure of CES1 activity.
Measured: Predose and 3 hours post-dose
Secondary outcomes (1)
Metabolomic Profile
Three samples for each participant during the trials (as indicated above). Metabolomics will be assessed with focus on lipids (lipid platform) and with use of usual concentration measures (eg nanomolar (nM))
Measured: Predose/pre-meal, predose/post-meal and 3 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carboxylesterase 1 (CES1) GenotypeStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Mental Health Centre Sct. Hans (Denmark), University of Copenhagen, The Leiden Academic Center for Drug Research (LACDR), Duke University
- Responsible party
- Principal investigator, Claus Stage, Bispebjerg Hospital
- Investigators
- Claus Stage, M.D., Principal investigator, Department of Clinical Pharmacology, Bispebjerg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147535
- Sponsor's protocol ID
- INDICES-WP2-2
- Status last verified
- Oct 2014
- First submitted
- 22 May 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CES1 Genotype on Metabolism of Methylphenidate
- ClinicalTrials.gov ID
- NCT02147535
- Acronym / sponsor ID
- INDICES-WP2-2
- Conditions
- Carboxylesterase 1 (CES1) Genotype, CES1 Activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Mental Health Centre Sct. Hans (Denmark), University of Copenhagen, The Leiden Academic Center for Drug Research (LACDR), Duke University
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 26 May 2014 (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.
The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of methylphenidate, a CES1 dependent drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: Methylphenidate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- > 18 years old
- Caucasian
Key exclusion criteria (6 listed)
- Chronic disease (except hay fever and eczema)
- Pregnancy
- Smoking
- High level of alcohol consumption (> 21 units per week for men and 14 for women)
- Known allergy towards methylphenidate
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 |
|---|---|---|
| MethylphenidateAlso: Ritalin10 mg as a single dose followed by one blood sample 3 hours post-dose | Drug | Methylphenidate |
Primary outcome
Plasma concentration of methylphenidate and ritalinic acid
Time frame: Predose and 3 hours post-dose
We are looking at the ratio of methylphenidate to ritalinic acid (metabolite) 3 hours post-dose as a measure of CES1 activity.
1 secondary outcome
Metabolomic Profile
Time frame: Predose/pre-meal, predose/post-meal and 3 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
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RecruitingObservational study
Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients
Solid Cancer, Gastric (Cardia, Body) Cancer
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.
Claus Stage, M.D. principal investigator
Department of Clinical Pharmacology, Bispebjerg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Carboxylesterase 1 (CES1) Genotype and CES1 Activity, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 13 Oct 2014. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma concentration of methylphenidate and ritalinic acid (time frame: Predose and 3 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2014.