Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: CapScan intestinal sampling device

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • Silicon Valley Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Envivo Bio Inc
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: February 18, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EB-03; 1R21CA260665-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes