Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol

NorthShore University HealthSystem

Status and phase

Terminated

Phase 2

Conditions

Ulcerative Colitis

Treatments

Drug: Rectal dialysis

Study type

Interventional

Funder types

Other

Identifiers

NCT04032652

EH 11-364

Details and patient eligibility

About

The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in the left colon.

Full description

Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum. The tablet dissolves at a pH 7 or greater, allowing mesalazine release in the terminal ileum and throughout the colon; hence, it would be anticipated that this form of 5-ASA will produce higher concentrations in the left colon in patients with active ulcerative colitis compared to other immediate release forms of 5-ASA. However, preliminary research using dynamic computer modeling and simulation predicted that patients with active ulcerative colitis (characterized by an increased stool frequency) treated with Asacol® and Lialda (another delayed release formulation) will achieve very low 5-ASA levels in the sigmoid colon and rectum. The model predicts that these 5-ASA preparations will be relatively ineffective in treating the left side of the colon in active ulcerative colitis.

Enrollment

2 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Eligible subjects would be healthy males and females
18-45 years of age (inclusive)
Within 20% of normal body weight at screening
Who are able to give written informed consent.

Exclusion criteria

History of any chronic illness
Evidence of significant organic or psychiatric disease on a brief health questionnaire
A history or presence of any condition causing malabsorption or an effect on gastrointestinal motility
A history of any gastrointestinal surgery
A history of acute or chronic renal insufficiency
Pre existing liver disease
A history of severe allergic reaction to salicylates, aminosalicylates or any of the ingredients of Asacol® tablets or a history of multiple food/drug allergies or if they are pregnant or lactating.
Subjects will be required to refrain from any prescription or nonprescription drug or herbal products except their birth control medications for gastrointestinal disorders for 7 days prior to dosing and during the study, till its completion at the end of the fifth visit.