Impact of CES1 Genotype on Metabolism of Methylphenidate

NCT ID: NCT02147535

Last Updated: 2014-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carboxylesterase 1 (CES1) Genotype CES1 Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Methylphenidate

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

10 mg as a single dose followed by one blood sample 3 hours post-dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methylphenidate

10 mg as a single dose followed by one blood sample 3 hours post-dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ritalin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Ministry of Science, Technology and Innovation, Denmark

OTHER_GOV

Sponsor Role collaborator

Mental Health Centre Sct. Hans (Denmark)

UNKNOWN

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

The Leiden Academic Center for Drug Research (LACDR)

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Claus Stage

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claus Stage, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Bispebjerg University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Clinical Pharmacology, Bispebjerg University Hospital

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

INDICES-WP2-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Methylphenidate in Myotonic Dystrophy Type 1
NCT01421992 COMPLETED PHASE2/PHASE3
Motivation and Methylphenidate
NCT03190681 COMPLETED EARLY_PHASE1