Trial Details
Not RecruitingBasic Information
| Clinical ID | c2015 |
|---|---|
| Identifier | ACTRN12624001448538 |
| Trial Title | Concentrations of Thioguanine and its metabolite 6-TGN in Blood and Colon Tissue Samples and the Drug Effect in Active Ulcerative Colitis Patients Administered Extended-release Thioguanine tablets |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Inflammatory Bowel Disease;Active Ulcerative Colitis; Inflammatory Bowel Disease Active Ulcerative Colitis;Oral and Gastrointestinal - Inflammatory bowel disease |
| Interventions | Administration of thioguanine by extended-release oral tablets once daily, Cohort 1 has 6 participants who will receive 20mg for 14 weeks. If there is evidence of efficacy and no significant toxicity after 14 weeks of thioguanine administration in cohort 1, a second cohort of 6 participants will start, after Day 99 in cohort 1, and receive 10 mg daily for 14 weeks. Adherence monitored by product return, and pharmacokinetics on day 1 and day 99. |
Participant Information
| Sponsor | Douglas Pharmaceuticals |
|---|---|
| City | - |
| Country/Region | New Zealand |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, ELDER, OLDER_ADULT |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | PHASE1 |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |