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Trial record 48 of 439 for:    Methylphenidate

Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype

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ClinicalTrials.gov Identifier: NCT02135263
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : July 30, 2014
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Gesche Jurgens, Bispebjerg Hospital

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
Carboxylesterase 1 (CES1) Genotype CES1 Activity Drug: Methylphenidate Drug: Enalapril Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : April 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate Drug: Methylphenidate
10 mg as a single dose followed by blood samples for the next 33 hours
Other Name: Ritalin

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




Primary Outcome Measures :
  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 Outcome Measures :
  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))



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135263


Locations
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Denmark
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
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Principal Investigator: Gesche Jürgens, M.D. Department of Clinical Pharmacology, Bispebjerg University Hospital

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Responsible Party: Gesche Jurgens, M.D., Ph.D., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02135263     History of Changes
Other Study ID Numbers: INDICES-WP2
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Methylphenidate
Enalapril
Enalaprilat
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antihypertensive Agents