Not Yet RecruitingPhase 1ACTRN12624001448538

The Pharmacokinetics and the Effect of Extended-release Thioguanine Tablets on Symptoms in Adults with Ulcerative Colitis.

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

Sponsor

Douglas Pharmaceuticals

Enrollment

12 participants

Start Date

Jan 13, 2025

Study Type

Interventional

Conditions

Inflammatory Bowel Disease Active Ulcerative Colitis

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

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Patients with active ulcerative colitis

Exclusion Criteria7

Severe extensive colitis.
Hospitalization for exacerbation of UC requiring intravenous (IV) steroids within 12 weeks of screening
A deficient (homozygous or heterozygous) Thiopurine S-methyl transferase (TPMT) enzyme activity or Nudix hydrolase 15 (NUDT15) genotype
Gastrointestinal infection
Previous exposure to TG and did not respond
Previous exposure to AZA and MP within 4 weeks prior to Day 1
Chronic hepatitis or abnormal liver biochemistry

Interested in this trial?

Get notified about updates and connect with the research team.

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

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.