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Completed

NCT Number: NCT02147535

Impact of CES1 Genotype on Metabolism of Methylphenidate

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.

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Key information

Conditions

Carboxylesterase 1 (CES1) Genotype CES1 Activity

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Clinical Pharmacology, Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Methylphenidate

Drug

10 mg as a single dose followed by one blood sample 3 hours post-dose

Other names: Ritalin

Primary outcomes

  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 outcomes

  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))

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Duke University
  • Mental Health Centre Sct. Hans (Denmark)
  • The Leiden Academic Center for Drug Research (LACDR)
  • The Ministry of Science, Technology and Innovation, Denmark
  • University of Copenhagen

Registry information

Important dates

Study start
2014
Primary completion
2014
First posted
May 26, 2014
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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