Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Trial website

Contact information



Primary contact

Dr Vincent Yip


Contact details

Wolfson Centre for Personalised Medicine
Department of Pharmacology
Block A:
Waterhouse Buildings
15 Brownlow Street
L69 3GL
United Kingdom
+44 151 794 5543

Additional identifiers

EudraCT number

2012-004700-35 number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

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

Ethics approval

18/12/2012, ref: 12/NW/0780

Study design

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

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


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


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

Intervention type



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants

Planned Sample Size: 8; UK Sample Size: 8

Total final enrolment


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Centre for Personalised Medicine
L69 3GL
United Kingdom

Sponsor information


Royal Liverpool and Broadgreen University NHS Trust (UK)

Sponsor details

Prescot Street
L7 8XP
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

2016 results in thesis (added 19/02/2020)

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

9/02/2020: The following changes have been made: 1. A thesis link has been added to the publication and dissemination plan. 2. The final enrolment number has been added from the thesis. 02/06/2017: No publications found in PubMed, verifying study status with principal investigator