NCT02147535

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 methylphenidate, a CES1 dependent drug.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

5 months

First QC Date

May 22, 2014

Last Update Submit

October 10, 2014

Conditions

Carboxylesterase 1 (CES1) GenotypeCES1 Activity

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Metabolomic Profile

    Predose/pre-meal, predose/post-meal and 3 hours post-dose

Study Arms (1)

Methylphenidate

EXPERIMENTAL
Drug: Methylphenidate

Interventions

MethylphenidateDRUG

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

Also known as: Ritalin
Methylphenidate

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \> 18 years old
  • Caucasian

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Interventions

Methylphenidate

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Claus Stage, M.D.

    Department of Clinical Pharmacology, Bispebjerg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 22, 2014

First Posted

May 26, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Last Updated

October 13, 2014

Record last verified: 2014-10

Locations

DK(1)