Condition category
Nervous System Diseases
Date applied
22/10/2014
Date assigned
22/10/2014
Last edited
05/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Carbamazepine is a drug used to treat epileptic seizures and nerve pain. The aim of this study is to test if this drug or its components can bind to proteins within the body and can create allergic reactions for people who are genetically prone to such reactions. We aim to find out the levels of the drug carbamazepine and its components following a single dose of carbamazepine.

Who can participate?
Healthy men aged between 18 and 55 years.

What does the study involve?
Participants will be asked to attend the clinical research unit at the Royal Liverpool Hospital. They will screened for suitability to take part in the study. If suitable they will be asked to return for another visit where they will be prescribed a single dose of carbamazepine. Before taking this dose they will be asked to provide a blood sample and then blood samples will be taken at regular intervals up to 72 hours after taking the drug. Urine samples will also be taken during the 72 hours.

What are the possible benefits and risks of participating?
There will be no direct benefits to participants. The risks of participating include pain and bruising associated with blood sampling. We will minimise this risk as only healthcare professionals trained in taking blood samples will be allowed to perform these procedures.

Where is the study run from?
The Royal Liverpool University Hospital (UK).

When is the study starting and how long is it expected to run for?
August 2013 to December 2013.

Who is funding the study?
Medical Research Council (MRC) (UK).

Who is the main contact?
Dr Vincent Yip
vyip@liv.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vincent Yip

ORCID ID

Contact details

Wolfson Centre for Personalised Medicine
Department of Pharmacology
Block A:
Waterhouse Buildings
15 Brownlow Street
Liverpool
L69 3GL
United Kingdom
vyip@liv.ac.uk

Additional identifiers

EudraCT number

2012-004700-35

ClinicalTrials.gov number

Protocol/serial number

13845

Study information

Scientific title

Pharmacokinetic investigation into the formation of carbamazepine metabolites and carbamazepine-protein conjugates in healthy volunteers: a non-randomised study

Acronym

PICME

Study hypothesis

Carbamazepine or carbamazepine metabolites are reactive and can bind intracellular proteins that stimulate hypersensitivity reactions in patients with genetic suscepitibility.

Ethics approval

12/NW/0780; First MREC approval date 18/12/2012

Study design

Non-randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Genetics; Subtopic: Genetics Research and Congenital Disorders (all subtopics); Disease: Genetics Research and Congenital Disorders

Intervention

Healthy volunteers will be given a single 400 mg dose of carbamazepine
Follow Up Length: 1 month(s); Study Entry: Registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pharmacokinetic analyses; Timepoint(s): pre-dose, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours; Methods: High performance liquid chromatography and tandem mass spectrometry

Secondary outcome measures

Not provided at time of registration

Overall trial start date

24/07/2013

Overall trial end date

30/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject is willing and able to give written informed consent
2. Healthy male subjects between 18 and 55 years of age inclusive
3. Subject’s body weight is between 50 and 100 kg
4. Subject’s body mass index is between 18 and 32 kg/m2

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 8; UK Sample Size: 8

Participant exclusion criteria

1. Subject is not willing to take part or unable to give written informed consent
2. Subject has clinically significant abnormal medical history or physical exam
3. Subject has history of febrile illness within 4 weeks prior to admission
4. Subject has clinically significant abnormal laboratory test at screening including HBV/HCV/HIV
5. Subject has taken any interacting prescription or non-prescription drug, or dietary supplements within 2 weeks prior to study admission. Herbal supplements must be discontinued at least 4 weeks prior to admission to the clinical research facility
6. Subject possesses either the HLA-B*1502 or HLA-A* 3101 genotype
7. Subject has a clinically significant ECG abnormality – prolonged corrected QT >450 ms, 2nd or 3rd degree atrioventricular conduction block
8. Subject has known hypersensitivity to carbamazepine or structurally related drugs (e.g. tricyclic antidepressants) or any other component of the formulation
9. Subject with history of bone marrow depression
10. Subject with history of hepatic porphyrias (e.g. intermittent porphyria, variegate porphyria, porphyria cutanea tarda)
11. Subject has taken part on another research study within 90 days of commencement
12. Subject has any condition which in the opinion of the investigator will interfere with the study

Recruitment start date

24/07/2013

Recruitment end date

30/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Centre for Personalised Medicine
Liverpool
L69 3GL
United Kingdom

Sponsor information

Organisation

Royal Liverpool and Broadgreen University NHS Trust (UK)

Sponsor details

Prescot Street
Liverpool
L7 8XP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes