Clinical trial NCT05749068: Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Envivo Bio Inc
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

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.

Eligibility 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:

* • 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

Primary outcomes:
measure: Regional Collection of Metabolites and Gut Microbiota
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Silicon Valley Gastroenterology
state: California
Study officials:
References: