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NCT00937872

A Clinical Study to Evaluate the Pharmacokinetics and the Absolute Bioavailability of SRT2104 Given as a 250mg Oral Suspension and Intravenous Microdose of 100 µg Carbon-14 Radio-labeled SRT2104 in Healthy Male Subjects

Completed Phase 1 Last updated 5 June 2017
What this trial tests

Phase 1 trial testing 250 mg SRT2104 Suspension in Diabetes Mellitus, Type 2 in 9 participants. Completed in 22 December 2008.

Timeline
22 November 2008
Primary endpoint
22 December 2008
22 December 2008

Quick facts

Lead sponsorSirtris, a GSK Company
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment9
Start date22 November 2008
Primary completion22 December 2008
Estimated completion22 December 2008
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Sirtris, a GSK Company — full company profile →

Who can join

Adults 18 to 65, male only, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study is to determine the absolute bioavailability of SRT2104 as a 250 mg suspension, and to define the intravenous pharmacokinetics of SRT2104. The secondary objective of this study is to assess the potential systemic metabolite burden of SRT2104, and to provide plasma and urine samples for subsequent metabolite profiling and identification.

Publications & conference data

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

  1. Emerging roles of SIRT1 in fatty liver diseases.
    Ding RB, Bao J, Deng CX. · · 2017 · cited 275× · PMID 28808418 · DOI 10.7150/ijbs.19370
  2. Oxidative stress and epigenetic regulation in ageing and age-related diseases.
    Cencioni C, Spallotta F, Martelli F, Valente S, et al · · 2013 · cited 137× · PMID 23989608 · DOI 10.3390/ijms140917643
  3. 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
  4. 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
  5. The Endothelium as a Target for Anti-Atherogenic Therapy: A Focus on the Epigenetic Enzymes EZH2 and SIRT1.
    Fledderus J, Vanchin B, Rots MG, Krenning G. · · 2021 · cited 19× · PMID 33562658 · DOI 10.3390/jpm11020103
  6. Roles of Sirtuins in Hearing Protection.
    Koo C, Richter CP, Tan X. · · 2024 · cited 3× · PMID 39204103 · DOI 10.3390/ph17080998
  7. Targeting both ferroptosis and pyroptosis may represent potential therapies for acute liver failure.
    Xing ZY, Zhang CJ, Liu LJ. · · 2024 · cited 2× · PMID 39351426 · DOI 10.3748/wjg.v30.i33.3791

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Other recruiting trials for Diabetes Mellitus, Type 2

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Data sources for this page

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/NCT00937872.

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