None listed
Conditions
Brief summary
A controlled release oral formulation of thioguanine is being developed by Douglas Pharmaceuticals for treatment of IBD. As part of the development program it is planned to measure mucosal tissue concentrations of the drug after administration. This study is to develop the methodology for measuring tissue concentrations of thioguanine in rectal biopsy tissue after thioguanine rectal administration. The patients have previously been treated successfully with thioguanine 20mg dissolved in 50ml of Pentasa enema. Two of these patients will have daily treatment for 7 days before flexible sigmoidoscopy to obtain rectal biopsy samples to measure thioguanine.
Interventions
Participants will self administer a rectal enema preparation of Pentasa enema 500mg combined with thioguanine 20mg daily for 7 days. This will be followed by a single 5-hour visit to the study clinic during which participants will have a flexible sigmoidoscopy performed by a registered gastroenterologist and rectal biopsies taken to determine tissue thioguanine concentration. Immediately following the flexible sigmoidoscopy, participants will have one further rectal enema with Pentasa and thiog
Participants will self administer a rectal enema preparation of Pentasa enema 500mg combined with thioguanine 20mg daily for 7 days. This will be followed by a single 5-hour visit to the study clinic during which participants will have a flexible sigmoidoscopy performed by a registered gastroenterologist and rectal biopsies taken to determine tissue thioguanine concentration. Immediately following the flexible sigmoidoscopy, participants will have one further rectal enema with Pentasa and thioguanine and 4 blood samples taken over 4 hours to determine thioguanine concentration. Adherence will be determined by daily medication record and pill return count.
Sponsors
Douglas Pharmaceuticals Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients previously treated with Pentasa/thioguanine enemas for proctitis
Exclusion criteria
Unable to provide informed consent
Outcome results
None listed