Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine

Envivo Bio

Status

Completed

Conditions

Healthy

Treatments

Device: CapScan intestinal sampling device

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT05749068

1R21CA260665-01A1 (U.S. NIH Grant/Contract)

EB-03

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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