Impact of CES1 Genotype on Metabolism of Methylphenidate

Carboxylesterase 1 (CES1) Genotype Clinical Trial

Official title:

Impact of CES1 Genotype on Metabolism of Methylphenidate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147535
• Other study ID #: INDICES-WP2-2
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2014
• Last updated: October 10, 2014
• Start date: March 2014

Study information

• Verified date: October 2014
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Carboxylesterase 1 (CES1) Genotype
• CES1 Activity

Intervention

Drug:
• Methylphenidate
10 mg as a single dose followed by one blood sample 3 hours post-dose

Locations

Country	Name	City	State
Denmark	Department of Clinical Pharmacology, Bispebjerg University Hospital	Copenhagen

Sponsors (6)

Lead Sponsor	Collaborator
Bispebjerg Hospital	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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of methylphenidate and ritalinic acid	We are looking at the ratio of methylphenidate to ritalinic acid (metabolite) 3 hours post-dose as a measure of CES1 activity.	Predose and 3 hours post-dose	No
Secondary	Metabolomic Profile	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))	Predose/pre-meal, predose/post-meal and 3 hours post-dose	No