Pharmacokinetics of 6-thioguanine
| ISRCTN | ISRCTN49579665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49579665 |
| Protocol serial number | N/A |
| Sponsor | VU University Medical Centre (VUMC) (The Netherlands) |
| Funder | VU University Medical Centre (VUMC) (The Netherlands) |
- Submission date
- 27/02/2007
- Registration date
- 27/02/2007
- Last edited
- 27/02/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K H N de Boer
Scientific
Scientific
VU University Medical Centre
Department of Gastroenterology and Hepatology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| KHN.deBoer@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, non-controlled, clinical trial |
| Secondary study design | Single-centre |
| Scientific title | |
| Study objectives | Oral 6-thioguanine (6TG) results in a high intra-hepatic exposure to 6TG generated metabolites. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Irritable Bowel Syndrome (IBS), Ulcerative colitis, Crohn's Disease |
| Intervention | Patients will receive both 6TG orally and intravenously. On set times (for eight hours) blood will be drawn to determine the concentrations of different metabolites and enzymes. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 6-thioguanine |
| Primary outcome measure(s) |
Determination of first pass effect of 6TG metabolites. |
| Key secondary outcome measure(s) |
Determination of influence of different enzymes on 6TG metabolism. |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 16 |
| Key inclusion criteria | 1. Irritable Bowel Disease (IBD) 2. In need of immunosuppressants 3. Intolerant to azathioprine or methotrexate |
| Key exclusion criteria | 1. Concomitant use of drugs interfering with thiopurine metabolism 2. Pregnancy/lactation |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
