HealthyNCT05749068
Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine
A study testing CapScan intestinal sampling device in people with Healthy, run by Envivo Bio Inc at 1 site in United States.
Trial summary
Evaluation of the CapScan intestinal collection device in characterizing the metabolism of sulfasalazine in the digestive tracts of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CapScan intestinal sampling device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Silicon Valley Gastroenterology
Mountain View, California, 94040
About this study
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
Evaluation of the CapScan intestinal collection device in characterizing the metabolism of sulfasalazine in the digestive tracts of healthy volunteers.
Read the 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.
- Conditions
- Healthy
- Being tested
- CapScan intestinal sampling device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapScan intestinal sampling deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Open label experimental arm Receives: Device: CapScan intestinal sampling device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Sep 2022
- Primary completion15 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Envivo Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749068
- Sponsor's protocol ID
- EB-03
- Other IDs
- 1R21CA260665-01A1
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2023
- Last updated
- 6 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05749068
- Acronym / sponsor ID
- EB-03
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Envivo Bio IncIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Posted 6 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: CapScan intestinal sampling deviceOpen label experimental arm |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- • Known or suspected gastrointestinal obstructions, strictures or fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapScan intestinal sampling deviceCapScan 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. | Device | Experimental |
Primary outcome
Regional Collection of Metabolites and Gut Microbiota
Time frame: 2 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CapScan intestinal sampling device in people with Healthy, run by Envivo Bio Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Collection of Metabolites and Gut Microbiota (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.