Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine

NCT05749068 | Completed Results FDA Device

• 2 other identifiers: EB-031R21CA260665-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

Open label experimental arm

Device: CapScan intestinal sampling device

Interventions

CapScan intestinal sampling device 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.

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Envivo Bio Inc: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Silicon Valley Gastroenterology

Mountain View, California, 94040, United States

Location

Results Point of Contact

• Title: Dr. George Triadafilopoulos
• Organization: Silicon Valley Gastroenterolgy

info@siliconvalleygi.com

(650) 988-7530

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: September 1, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 30, 2022
• Last Updated: February 6, 2024
• Results First Posted: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)