Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02135263

Enrollment

Registered

2014-05-09

Start date

2012-04-30

Completion date

2014-05-31

Last updated

2014-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carboxylesterase 1 (CES1) Genotype, CES1 Activity

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.

Interventions

DRUGMethylphenidate

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

DRUGEnalapril

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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
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
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
Terminal half life (t½) of enalapril	Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose

Secondary

Measure	Time frame	Description
Metabolomic profile	Predose/pre-meal, predose/post-meal, 2 and 6 hours post-dose	Four samples for each participant during the methylphenidate trials (as indicated above). Metabolomics will be assessed with focus on lipids (lipid platform) and with use of usual concentration measures (eg nanomolar (nM))

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026