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Impact of CES1 Genotype on Metabolism of Methylphenidate

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ClinicalTrials.gov Identifier: NCT02147535
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : October 13, 2014
Sponsor:
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
Information provided by (Responsible Party):
Claus Stage, Bispebjerg Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Carboxylesterase 1 (CES1) Genotype CES1 Activity Drug: Methylphenidate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of CES1 Genotype on Metabolism of Methylphenidate
Study Start Date : March 2014
Actual Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate Drug: Methylphenidate
10 mg as a single dose followed by one blood sample 3 hours post-dose
Other Name: Ritalin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147535


Locations
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Denmark
Department of Clinical Pharmacology, Bispebjerg University Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
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
Investigators
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Principal Investigator: Claus Stage, M.D. Department of Clinical Pharmacology, Bispebjerg University Hospital

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Responsible Party: Claus Stage, M.D., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02147535     History of Changes
Other Study ID Numbers: INDICES-WP2-2
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents