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Carboxylesterase 1 (CES1) Genotype | Impact of CES1 Genotype on Metabolism of Methylphenidate

Carboxylesterase 1 (CES1) Genotype research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Carboxylesterase 1 (CES1) Genotype

CES1 Activity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Methylphenidate10 mg as a single dose followed by one blood sample 3 hours post-dose

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Methylphenidate

Study Status

Completed

Start Date: March 2014

Completed Date:

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Plasma concentration of methylphenidate and ritalinic acid

Secondary Outcome: Metabolomic Profile

Study sponsors, principal investigator, and references

Principal Investigator: Claus Stage, M.D.

Lead Sponsor: Bispebjerg Hospital

Collaborator: The Ministry of Science, Technology and Innovation, Denmark

More information:https://clinicaltrials.gov/show/NCT02147535

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