Pharmacokinetic investigation into the formation of carbamazepine metabolites and carbamazepine-protein conjugates in healthy volunteers

Not Applicable

Completed

• Conditions: Topic: Genetics; Subtopic: Genetics Research and Congenital Disorders (all subtopics); Disease: Genetics Research and Congenital Disorders; Nervous System Diseases

• Registration Number: ISRCTN00131154
• Lead Sponsor: Royal Liverpool and Broadgreen University NHS Trust (UK)

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33217013/ (added 21/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-12-30
• Study Start: 2014-10-22
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 8

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
ot provided at time of registration