Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedJuly 30, 2014
July 1, 2014
2.1 years
July 1, 2013
July 29, 2014
Conditions
Outcome Measures
Primary Outcomes (8)
Peak plasma concentration (Cmax) of methylphenidate
Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Time to peak plasma concentration (Tmax) of methylphenidate
Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Terminal half life (t½) of methylphenidate
Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Area under the plasma concentration versus time curve (AUC) of methylphenidate
Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Peak plasma concentration (Cmax) of enalapril
Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Time to peak plasma concentration (Tmax) of enalapril
Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Terminal half life (t½) of enalapril
Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Area under the plasma concentration versus time curve (AUC) of enalapril
Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Secondary Outcomes (1)
Metabolomic profile
Predose/pre-meal, predose/post-meal, 2 and 6 hours post-dose
Study Arms (2)
Methylphenidate
EXPERIMENTALEnalapril
EXPERIMENTALInterventions
10 mg as a single dose followed by blood samples for the next 33 hours
10 mg as a single dose followed by blood samples for the next 72 hours
Eligibility Criteria
You may qualify if:
- \> 18 years old
- Caucasian
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bispebjerg Hospitallead
- The Ministry of Science, Technology and Innovation, Denmarkcollaborator
- Mental Health Centre Sct. Hans (Denmark)collaborator
- University of Copenhagencollaborator
- The Leiden Academic Center for Drug Research (LACDR)collaborator
- Duke Universitycollaborator
Study Sites (1)
Department of Clinical Pharmacology, Bispebjerg University Hospital
Copenhagen, 2400, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gesche Jürgens, M.D.
Department of Clinical Pharmacology, Bispebjerg University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D.
Study Record Dates
First Submitted
July 1, 2013
First Posted
May 9, 2014
Study Start
April 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
July 30, 2014
Record last verified: 2014-07