Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine
Study Details
Study Description
Brief Summary
Evaluation of the CapScan intestinal collection device in characterizing the metabolism of sulfasalazine in the digestive tracts of healthy volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Open label experimental arm |
Device: CapScan intestinal sampling device
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.
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Outcome Measures
Primary Outcome Measures
- Regional collection of metabolites and gut microbiota [2 days]
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.
Eligibility Criteria
Criteria
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:
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• Known or suspected gastrointestinal obstructions, strictures or fistula
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Known or suspected moderate to severe dysmotility, by the judgement of the principal investigator
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Gastroparesis
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A swallowing disorder
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Known intolerance, reaction or hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates
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Urinary obstruction
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Porphyria
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Glucose-6-phosphate dehydrogenase deficiency
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Known or suspected infection with severe acute respiratory syndrome, HIV, hepatitis B virus or hepatitis C virus
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Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding.
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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.
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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.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Silicon Valley Gastroenterology | Mountain View | California | United States | 94040 |
Sponsors and Collaborators
- Envivo Bio Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EB-03