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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: Completed Phase 1 study, sponsored by Sirtris, a GSK Company.
NCT01453491 is a Phase 1 study that has completed, run by Sirtris, a GSK Company. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01453491 record still lists
NCT01453491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which SRT2104 is the first listed.
NCT01453491 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01453491's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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