Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-25 @ 3:03 PM
Study NCT ID:
NCT05749068
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2023-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine
Sponsor:
Envivo Bio Inc
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21CA260665-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |