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Completed Phase 1 Interventional

A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis

ClinicalTrials.gov ID: NCT01453491

Public ClinicalTrials.gov record NCT01453491. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 9:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1b, Exploratory Study to Assess the Safety, Tolerability, Colonic Tissue Exposure, and Anti-Inflammatory Effects of Two Different Doses of SRT2104 in Subjects With Mild to Moderate Ulcerative Colitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01453491
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Sirtris, a GSK Company
Industry
Enrollment
17 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 13, 2012 (Actual)
Primary completion
Mar 18, 2013 (Actual)
Completion
Mar 18, 2013 (Actual)
Last update posted
Jun 1, 2017

2012 – 2013

United States locations

U.S. sites
13
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
GSK Investigational Site Anaheim California 92801 —
GSK Investigational Site Bristol Connecticut 06010 —
GSK Investigational Site Owensboro Kentucky 42303 —
GSK Investigational Site Chevy Chase Maryland 20815 —
GSK Investigational Site Towson Maryland 21204 —
GSK Investigational Site Chesterfield Michigan 48047 —
GSK Investigational Site Great Neck New York 11021 —
GSK Investigational Site New York New York 10029 —
GSK Investigational Site Raleigh North Carolina 27612 —
GSK Investigational Site Beavercreek Ohio 45432 —
GSK Investigational Site Columbus Ohio 43215 —
GSK Investigational Site Oklahoma City Oklahoma 73104 —
GSK Investigational Site Jackson Tennessee 38305 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01453491, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 1, 2017 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01453491 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →