None listed
Conditions
Brief summary
Cohort 1: Six patients with active ulcerative colitis will be given thioguanine by extended-release tablet 20mg for 99 days. Efficacy and safety will be assessed and a further objective is to determine blood and colon tissue concentrations of thioguanine and it's metabolite 6-TGN following extended-release tablet administration. Cohort 2: If the 20mg dose is seen to show evidence of efficacy and safety, a 10mg dose will also be trialed in 6 patients for 14 weeks with the same parameters measured as for cohort 1.. Secondary objectives include: • to compare rectal and blood concentrations of 6-TGN with those seen previously after immediate release tablet administration in previous studies
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.
Sponsors
Douglas Pharmaceuticals
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with active ulcerative colitis
Exclusion criteria
1. Severe extensive colitis. 2. Hospitalization for exacerbation of UC requiring intravenous (IV) steroids within 12 weeks of screening 3. A deficient (homozygous or heterozygous) Thiopurine S-methyl transferase (TPMT) enzyme activity or Nudix hydrolase 15 (NUDT15) genotype 4. Gastrointestinal infection 5. Previous exposure to TG and did not respond 6. Previous exposure to AZA and MP within 4 weeks prior to Day 1 7. Chronic hepatitis or abnormal liver biochemistry
Outcome results
None listed