- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02147535
Impact of CES1 Genotype on Metabolism of Methylphenidate
October 10, 2014 updated by: Claus Stage, Bispebjerg Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2400
- Department of Clinical Pharmacology, Bispebjerg University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- > 18 years old
- Caucasian
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Methylphenidate
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10 mg as a single dose followed by one blood sample 3 hours post-dose
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Predose and 3 hours post-dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolomic Profile
Time Frame: Predose/pre-meal, predose/post-meal and 3 hours post-dose
|
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))
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Predose/pre-meal, predose/post-meal and 3 hours post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Claus Stage, M.D., Department of Clinical Pharmacology, Bispebjerg University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
May 22, 2014
First Submitted That Met QC Criteria
May 22, 2014
First Posted (Estimate)
May 26, 2014
Study Record Updates
Last Update Posted (Estimate)
October 13, 2014
Last Update Submitted That Met QC Criteria
October 10, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INDICES-WP2-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Massachusetts General HospitalMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Completed