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Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02135263
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)
44
Enrollment
1
Location
2
Arms
25
Duration (Months)
1.8
Patients Per Site Per Month

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 two CES1 dependent drugs, enalapril and methylphenidate.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methylphenidate

Drug: Methylphenidate
10 mg as a single dose followed by blood samples for the next 33 hours
Other Names:
  • Ritalin

    		•
    Experimental: Enalapril

    Drug: Enalapril
    10 mg as a single dose followed by blood samples for the next 72 hours
    Other Names:
  • Corodil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak plasma concentration (Cmax) of methylphenidate [Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose]

    2. Time to peak plasma concentration (Tmax) of methylphenidate [Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose]

    3. Terminal half life (t½) of methylphenidate [Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose]

    4. Area under the plasma concentration versus time curve (AUC) of methylphenidate [Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose]

    5. Peak plasma concentration (Cmax) of enalapril [Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose]

    6. Time to peak plasma concentration (Tmax) of enalapril [Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose]

    7. Terminal half life (t½) of enalapril [Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose]

    8. Area under the plasma concentration versus time curve (AUC) of enalapril [Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose]

    Secondary Outcome Measures

    1. Metabolomic profile [Predose/pre-meal, predose/post-meal, 2 and 6 hours post-dose]

      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))

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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 and enalapril

    • 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: Gesche Jürgens, M.D., Department of Clinical Pharmacology, Bispebjerg University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gesche Jurgens, M.D., Ph.D., Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT02135263
    Other Study ID Numbers:
    • INDICES-WP2
    First Posted:
    May 9, 2014
    Last Update Posted:
    Jul 30, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Enalapril
    Methylphenidate

    Study Results

    No Results Posted as of Jul 30, 2014