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

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

      • Copenhagen, Denmark, 2400
        • Department of Clinical Pharmacology, Bispebjerg University Hospital

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

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.
Predose and 3 hours post-dose

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))
Predose/pre-meal, predose/post-meal and 3 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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