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Completed

NCT Number: NCT02135263

Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype

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.

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Key information

Conditions

Carboxylesterase 1 (CES1) Genotype CES1 Activity

Age range

18 year and older

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 and enalapril
  • Permanent use of medication (contraception ok)

Treatment and study plan

Methylphenidate

Drug

10 mg as a single dose followed by blood samples for the next 33 hours

Other names: Ritalin

Enalapril

Drug

10 mg as a single dose followed by blood samples for the next 72 hours

Other names: Corodil

Primary outcomes

  1. Peak plasma concentration (Cmax) of methylphenidate

    Time frame: 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

    Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose

  3. Terminal half life (t½) of methylphenidate

    Time frame: 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

    Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose

  5. Peak plasma concentration (Cmax) of enalapril

    Time frame: 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

    Time frame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose

  7. Terminal half life (t½) of enalapril

    Time frame: 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

    Time frame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose

Secondary outcomes

  1. Metabolomic profile

    Time frame: 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))

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
2012
Primary completion
2014
Study completion
2014
First posted
May 9, 2014
Registry last updated
Jul 30, 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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