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Impact of CES1 Genotype on Metabolism of Methylphenidate

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02147535
Collaborator
The Ministry of Science, Technology and Innovation, Denmark (Other), Mental Health Centre Sct. Hans (Denmark) (Other), University of Copenhagen (Other), The Leiden Academic Center for Drug Research (LACDR) (Other), Duke University (Other)
78
Enrollment
1
Location
1
Arm

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
N/A
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 :
Mar 1, 2014
Actual Primary Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methylphenidate

Drug: Methylphenidate
10 mg as a single dose followed by one blood sample 3 hours post-dose
Other Names:
  • Ritalin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma concentration of methylphenidate and ritalinic acid [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 [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))

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • Principal Investigator: Claus Stage, M.D., Department of Clinical Pharmacology, Bispebjerg University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claus Stage, M.D., Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT02147535
    Other Study ID Numbers:
    • INDICES-WP2-2
    First Posted:
    May 26, 2014
    Last Update Posted:
    Oct 13, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Methylphenidate

    Study Results

    No Results Posted as of Oct 13, 2014