NCT00260247

Brief Summary

This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree. This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity. It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

April 22, 2015

Status Verified

March 1, 2005

Enrollment Period

1.5 years

First QC Date

November 28, 2005

Last Update Submit

April 21, 2015

Conditions

Metabolic Clearance Rate

Keywords

CYP3A4InductionOxcarbazepineCarbamazepineQuinidineHumanIn vivo

Outcome Measures

Primary Outcomes (1)

  • Formation clearance of 3-hydroxyquinidine

Secondary Outcomes (1)

  • Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.

Interventions

carbamazepine oxcarbazepineDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \< 30
  • Non smoker
  • No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
  • Informed consent

You may not qualify if:

  • signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
  • mental disease
  • participation in another clinical trial involving drugs with 3 months of randomization
  • donation of more than 500 mL blood within 3 months of randomization
  • intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, 5210, Denmark

Location

Study Officials

  • Per Damkier, MD, Ph.D.

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2005

First Posted

December 1, 2005

Study Start

April 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

April 22, 2015

Record last verified: 2005-03

Locations

DK(1)