Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype

NCT ID: NCT02135263

Last Updated: 2014-07-30

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carboxylesterase 1 (CES1) Genotype CES1 Activity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Methylphenidate

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

10 mg as a single dose followed by blood samples for the next 33 hours

Enalapril

Group Type EXPERIMENTAL

Enalapril

Intervention Type DRUG

10 mg as a single dose followed by blood samples for the next 72 hours

Interventions

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Methylphenidate

10 mg as a single dose followed by blood samples for the next 33 hours

Intervention Type DRUG

Enalapril

10 mg as a single dose followed by blood samples for the next 72 hours

Intervention Type DRUG

Other Intervention Names

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Ritalin Corodil

Eligibility Criteria

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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 and enalapril
* Permanent use of medication (contraception ok)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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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

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Gesche Jurgens

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gesche Jürgens, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Bispebjerg University Hospital

Locations

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Department of Clinical Pharmacology, Bispebjerg University Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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INDICES-WP2

Identifier Type: -

Identifier Source: org_study_id

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