Impact of CES1 Genotype on Metabolism of Methylphenidate

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Methylphenidate

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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))

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bispebjerg Hospital
  • Collaborator
    • The Ministry of Science, Technology and Innovation, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claus Stage, M.D. – Bispebjerg Hospital
  • Overall Official(s)
    • Claus Stage, M.D., Principal Investigator, Department of Clinical Pharmacology, Bispebjerg University Hospital

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