Carboxylesterase 1 (CES1) GenotypePhase 4NCT02135263
Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype
A Phase 4 study testing Methylphenidate and Enalapril 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 two CES1 dependent drugs, enalapril and methylphenidate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carboxylesterase 1 (CES1) Genotype, CES1 Activity
- What is being tested?
- Methylphenidate and Enalapril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 and enalapril
- 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 two CES1 dependent drugs, enalapril and methylphenidate.
- Conditions
- Carboxylesterase 1 (CES1) Genotype, CES1 Activity
- Being tested
- Methylphenidate, Enalapril
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 blood samples for the next 33 hours
EnalaprilDrug
Also called Corodil
10 mg as a single dose followed by blood samples for the next 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | Not described Receives: Drug: Methylphenidate |
| Enalapril | Experimental | Not described Receives: Drug: Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of methylphenidate
Measured: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Time to peak plasma concentration (Tmax) of methylphenidate
Measured: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Terminal half life (t½) of methylphenidate
Measured: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Area under the plasma concentration versus time curve (AUC) of methylphenidate
Measured: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Peak plasma concentration (Cmax) of enalapril
Measured: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Time to peak plasma concentration (Tmax) of enalapril
Measured: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Terminal half life (t½) of enalapril
Measured: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Area under the plasma concentration versus time curve (AUC) of enalapril
Measured: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Secondary outcomes (1)
Metabolomic profile
Four samples for each participant during the methylphenidate 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, 2 and 6 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 posted9 May 2014 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionMay 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 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, Gesche Jurgens, Bispebjerg Hospital
- Investigators
- Gesche Jürgens, M.D., Principal investigator, Department of Clinical Pharmacology, Bispebjerg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135263
- Sponsor's protocol ID
- INDICES-WP2
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype
- ClinicalTrials.gov ID
- NCT02135263
- Acronym / sponsor ID
- INDICES-WP2
- Conditions
- Carboxylesterase 1 (CES1) Genotype, CES1 Activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 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
- Apr 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 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 two CES1 dependent drugs, enalapril and methylphenidate.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: Methylphenidate |
| Enalapril | Experimental | Drug: Enalapril |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 and enalapril
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 blood samples for the next 33 hours | Drug | Methylphenidate |
| EnalaprilAlso: Corodil10 mg as a single dose followed by blood samples for the next 72 hours | Drug | Enalapril |
Primary outcome
Peak plasma concentration (Cmax) of methylphenidate
Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Time to peak plasma concentration (Tmax) of methylphenidate
Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Terminal half life (t½) of methylphenidate
Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Area under the plasma concentration versus time curve (AUC) of methylphenidate
Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Peak plasma concentration (Cmax) of enalapril
Time frame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Time to peak plasma concentration (Tmax) of enalapril
Time frame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Terminal half life (t½) of enalapril
Time frame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Area under the plasma concentration versus time curve (AUC) of enalapril
Time frame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
1 secondary outcome
Metabolomic profile
Time frame: Predose/pre-meal, predose/post-meal, 2 and 6 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 30 Jul 2014.
Related trials for Carboxylesterase 1 (CES1) Genotype
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.
Gesche Jürgens, 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 and Enalapril 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 30 Jul 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?
Peak plasma concentration (Cmax) of methylphenidate (time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose). The study lists 8 primary outcomes in all. 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 30 Jul 2014.