Topic: Genetics
Conditions
Interventions
Healthy volunteers will be given a single 400 mg dose of carbamazepine
Follow Up Length: 1 month(s)
Sponsors
Royal Liverpool and Broadgreen University NHS Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed