Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine

Study Overview
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Brief Summary
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Evaluation of the CapScan intestinal collection device in characterizing the metabolism of sulfasalazine in the digestive tracts of healthy volunteers.

Detailed Description
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The objective is to evaluate the effectiveness of the CapScan intestinal collection device in characterizing the regional distribution of sulfasalazine, the metabolic breakdown products of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers.

Official Title
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An Open-label Study to Evaluate the Use of the CapScan Intestinal Collection Device to Measure the Regional Metabolism of Sulfasalazine in the Digestive Tracts of Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Device: CapScan intestinal sampling device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit. Physical Status Classification System 1 or 2. For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit and agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 14 days after the final dose of sulfasalazine. Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form Exclusion Criteria: • Known or suspected gastrointestinal obstructions, strictures or fistula Known or suspected moderate to severe dysmotility, by the judgement of the principal investigator Gastroparesis A swallowing disorder Known intolerance, reaction or hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates Urinary obstruction Porphyria Glucose-6-phosphate dehydrogenase deficiency Known or suspected infection with severe acute respiratory syndrome, HIV, hepatitis B virus or hepatitis C virus Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding. Use of concomitant medications, such as aspirin, antibiotics, laxatives and proton pump inhibitors that may interfere with the study in the judgement of the investigator. Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the principal investigator, to interfere with the conduct of the study. A clinical condition that, in the judgment of the principal investigator, could potentially pose a health risk to the subject while involved in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Open label experimental arm | Device: CapScan intestinal sampling device<br>* CapScan is an intestinal collection device used to characterize the regional distribution of sulfasalazine, the metabolic breakdown products of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional collection of metabolites and gut microbiota | Regional measurement of sulfasalazine in the intestinal lumen, the metabolic breakdown products of sulfasalazine and the gut microbiota in the digestive tracts of healthy volunteers. | 2 days |