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

• Status: Terminated
• Trial end date: 2014-12-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NorthShore University HealthSystem
• Treatments: Mesalamine

Criteria

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.