NCT01453491 is a Phase 1 clinical trial of SRT2104 in Colitis, Ulcerative, sponsored by Sirtris, a GSK Company.

Who is sponsoring NCT01453491?

NCT01453491 is sponsored by Sirtris, a GSK Company.

What drugs are being tested in NCT01453491?

Interventions in NCT01453491: SRT2104.

What condition does NCT01453491 study?

NCT01453491 studies Colitis, Ulcerative.

Is NCT01453491 still recruiting?

NCT01453491 is currently completed. Last updated 1 June 2017.

Last reviewed 2017-06-01 · How we verify

NCT01453491

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 1 June 2017

What this trial tests

Phase 1 trial testing SRT2104 in Colitis, Ulcerative in 17 participants. Completed in 18 March 2013.

Timeline

13 February 2012

Primary endpoint
18 March 2013

18 March 2013

Quick facts

Lead sponsor	Sirtris, a GSK Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	17
Start date	13 February 2012
Primary completion	18 March 2013
Estimated completion	18 March 2013
Sites	13 locations across United States

Drugs / interventions tested

SRT2104 — full drug profile →

Conditions studied

Colitis, Ulcerative — all drugs for Colitis, Ulcerative →

Sponsor

Sirtris, a GSK Company — full company profile →

Who can join

Adults 18 to 75, any sex, with Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Slowing ageing by design: the rise of NAD<sup>+</sup> and sirtuin-activating compounds.
Bonkowski MS, Sinclair DA. · · 2016 · cited 639× · PMID 27552971 · DOI 10.1038/nrm.2016.93
The sirtuin family in health and disease.
Wu QJ, Zhang TN, Chen HH, Yu XF, et al · · 2022 · cited 583× · PMID 36581622 · DOI 10.1038/s41392-022-01257-8
Regulation of Mitophagy by Sirtuin Family Proteins: A Vital Role in Aging and Age-Related Diseases.
Wan W, Hua F, Fang P, Li C, et al · · 2022 · cited 57× · PMID 35615591 · DOI 10.3389/fnagi.2022.845330
Emerging roles of SIRT1 activator, SRT2104, in disease treatment.
Chang N, Li J, Lin S, Zhang J, et al · · 2024 · cited 49× · PMID 38448466 · DOI 10.1038/s41598-024-55923-8
Assessing Colonic Exposure, Safety, and Clinical Activity of SRT2104, a Novel Oral SIRT1 Activator, in Patients with Mild to Moderate Ulcerative Colitis.
Sands BE, Joshi S, Haddad J, Freudenberg JM, et al · · 2016 · cited 37× · PMID 26595549 · DOI 10.1097/mib.0000000000000597
Quantifying Competition among Mitochondrial Protein Acylation Events Induced by Ethanol Metabolism.
Ali HR, Assiri MA, Harris PS, Michel CR, et al · · 2019 · cited 21× · PMID 30644754 · DOI 10.1021/acs.jproteome.8b00800
Preventing loss of sirt1 lowers mitochondrial oxidative stress and preserves C2C12 myotube diameter in an in vitro model of cancer cachexia.
Hain BA, Kimball SR, Waning DL. · · 2024 · cited 3× · PMID 38946587 · DOI 10.14814/phy2.16103

Verify or expand the search:

Other trials of SRT2104

Trials testing the same drug.

NCT01154101 — Study of the Clinical Activity, Safety, and Tolerability of SRT2104 in Subjects With Moderate to Severe Plaque-Type Psor · Phase 2 · completed
NCT01031108 — A Clinical Trial to Assess the Safety of Oral SRT2104 and Its Effects on Vascular Dysfunction in Otherwise Healthy Cigar · Phase 1 · completed
NCT01018017 — A Clinical Study to Assess the Safety, Tolerability, and Activity of Oral SRT2104 Capsules Administered for 28 Days to S · Phase 2 · completed
NCT01014117 — Effect of SRT2104 on Endotoxin-induced Inflammation · Phase 1 · completed
NCT00964340 — A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Health · Phase 1 · completed

Other recruiting trials for Colitis, Ulcerative

Currently open trials in the same condition.

NCT07302360 — A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis · recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
NCT07196748 — A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Col · Phase 3 · recruiting
NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany · recruiting
NCT06651281 — Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Coli · Phase 3 · recruiting

Other Sirtris, a GSK Company trials

Trials by the same sponsor.

NCT01702493 — A Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers · Phase 1 · completed
NCT01416376 — Effect of Multiple Dose Levels of SRT2379 on Endotoxin-Induced Inflammation · Phase 1 · completed
NCT01340911 — A Study in Healthy Male Volunteers to Investigate Different Doses of a New Drug for the Treatment of Metabolic Diseases · Phase 1 · completed
NCT01262911 — Effect of SRT2379 on Endotoxin-Induced Inflammation · Phase 1 · completed
NCT01154101 — Study of the Clinical Activity, Safety, and Tolerability of SRT2104 in Subjects With Moderate to Severe Plaque-Type Psor · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01453491 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sirtris, a GSK Company
Last refreshed: 1 June 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01453491.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing