Rectal and blood concentrations of thioguanine given by suppository in inflammatory bowel disease

Concentrations of Thioguanine and its metabolite 6TGN in Blood and Rectal Tissue Samples in Patients with Refractory Ulcerative Proctitis Administered Thioguanine by Suppository

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623001337662

Enrollment

Registered

2023-12-19

Start date

2023-12-20

Completion date

2024-04-30

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Seven patients with refractory ulcerative proctitis will be given thioguanine by suppository 20mg or 5 mg for 29 days. Efficacy and safety will be assessed but the main objective is to determine rectal tissue concentrations of thioguanine following rectal administration of thioguanine by suppository. Eight control patients without proctitis will be recruited to obtain rectal concentrations whilst on azathioprine, thioguanine orally or no thiopurine. Secondary objectives include: • to compare rectal and blood concentrations of 6-TGN after rectal administration with those seen previously after tablet/Pentasa enema administration rectally. • assessment of signals for efficacy and/or toxicity

Interventions

Administration of thioguanine by suppository once daily, 5mg or 20mg as determined by computer randomisation, rectally for 29 days. Adherence monitored by product return, and pharmacokinetics on day 1 and day 29.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with refractory ulcerative proctitis

Exclusion criteria

Unable to give informed consent

Outcome results