Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05749068
• Other study ID #: EB-03
• Secondary ID: 1R21CA260665-01A
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: February 2024
• Source: Envivo Bio Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 30, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Silicon Valley Gastroenterology	Mountain View	California

Sponsors (2)

Lead Sponsor	Collaborator
Envivo Bio Inc	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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