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NCT01453491 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis
A Phase 1 study, sponsored by Sirtris, a GSK Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01453491 is a Phase 1 study that has completed, run by Sirtris, a GSK Company. The registered enrollment target is 17 participants.
The verdict
NCT01453491, a Phase 1 study, has completed, sponsored by Sirtris, a GSK Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this research study is to: * 1\) Test the safety and tolerability of 2 different oral doses of SRT2104 in subjects with ulcerative colitis * 2\) Determine the amount of SRT2104 measured from a single blood sample in addition to colon and/or rectal tissue samples (biopsies) * 3\) Determine whether SRT2104 has any anti-inflammatory effect on the colon and/or rectum when taken orally for 8 weeks * 4\) Determine whether SRT2104 causes any detectable changes to specific biomarkers. A biomarker is a biological marker (or substance such as a protein) that is used as an indicator of changes in a biological state that corresponds to the risk or progression of a disease.
Interventions
- DRUG SRT2104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-02-13 |
| Est. Completion | 2013-03-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01453491
The ClinicalTrials.gov registry entry for NCT01453491 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sirtris, a GSK Company, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SRT2104 is the first listed.
NCT01453491 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01453491 about?
NCT01453491 is a clinical study titled "A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis". The purpose of this research study is to: * 1\) Test the safety and tolerability of 2 different oral doses of SRT2104 in subjects with ulcerative colitis * 2\) Determine the amount of SRT2104 measured from a single blood sample in addition to colon and/or rectal tissue samples (biopsies) * 3\) Dete...
What is the current status of trial NCT01453491?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2012-02-13. Estimated completion is 2013-03-18.
What interventions are being tested in trial NCT01453491?
The interventions under investigation include: SRT2104 (DRUG).
Who is sponsoring clinical trial NCT01453491?
This trial is sponsored by Sirtris, a GSK Company, which has 3 total clinical trials registered on ClinicalTrials.gov.
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