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Trial record 7 of 441 for:    Methylphenidate

Impact of CES1 Genotype on Metabolism of Methylphenidate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02147535
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : October 13, 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):
Claus Stage, Bispebjerg Hospital

Tracking Information
First Submitted Date  ICMJE May 22, 2014
First Posted Date  ICMJE May 26, 2014
Last Update Posted Date October 13, 2014
Study Start Date  ICMJE March 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02147535 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2014)
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))
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of CES1 Genotype on Metabolism of Methylphenidate
Official Title  ICMJE Impact of CES1 Genotype on Metabolism of Methylphenidate
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 methylphenidate, a CES1 dependent drug.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Carboxylesterase 1 (CES1) Genotype
  • CES1 Activity
Intervention  ICMJE Drug: Methylphenidate
10 mg as a single dose followed by one blood sample 3 hours post-dose
Other Name: Ritalin
Study Arms  ICMJE Experimental: Methylphenidate
Intervention: Drug: Methylphenidate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2014)
78
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2014)
75
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02147535
Other Study ID Numbers  ICMJE INDICES-WP2-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claus Stage, Bispebjerg Hospital
Study Sponsor  ICMJE Bispebjerg Hospital
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Claus Stage, M.D. Department of Clinical Pharmacology, Bispebjerg University Hospital
PRS Account Bispebjerg Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP