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N/A N=10 Device Feasibility

Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine

Healthy

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Regional Collection of Metabolites and Gut Microbiota — 10 participants with sulfasalazine detected

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CapScan intestinal sampling device (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Envivo Bio Inc
Primary completion
Oct 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Regional Collection of Metabolites and Gut Microbiota
10

Summary

Evaluation of the CapScan intestinal collection device in characterizing the metabolism of sulfasalazine 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05749068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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