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

31 maggio 2017 aggiornato da: Sirtris, a GSK Company

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

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

17

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Anaheim, California, Stati Uniti, 92801
        • GSK Investigational Site
    • Connecticut
      • Bristol, Connecticut, Stati Uniti, 06010
        • GSK Investigational Site
    • Kentucky
      • Owensboro, Kentucky, Stati Uniti, 42303
        • GSK Investigational Site
    • Maryland
      • Chevy Chase, Maryland, Stati Uniti, 20815
        • GSK Investigational Site
      • Towson, Maryland, Stati Uniti, 21204
        • GSK Investigational Site
    • Michigan
      • Chesterfield, Michigan, Stati Uniti, 48047
        • GSK Investigational Site
    • New York
      • Great Neck, New York, Stati Uniti, 11021
        • GSK Investigational Site
      • New York, New York, Stati Uniti, 10029
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, Stati Uniti, 27612
        • GSK Investigational Site
    • Ohio
      • Beavercreek, Ohio, Stati Uniti, 45432
        • GSK Investigational Site
      • Columbus, Ohio, Stati Uniti, 43215
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • GSK Investigational Site
    • Tennessee
      • Jackson, Tennessee, Stati Uniti, 38305
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Mild to moderately active ulcerative colitis as evidenced by Mayo score 6-10 (inclusive) with rectal bleeding score ≥1, endoscopy score between 2-3 (inclusive), and physician's rating of disease activity <3 at Day -5
  • Colonic inflammation extending proximal to the rectum (i.e., greater than 15 cm in extent) on baseline sigmoidoscopy at Day -5
  • Confirmed diagnosis of ulcerative colitis for at least 3 months prior to the Screening Visit (Visit 1)
  • Male or female between 18 and 75 years, inclusive
  • Body weight >50 kg and BMI ≥18 kg/m^2 at Screening (Visit 1)
  • Capable of giving written informed consent, and willing and able to comply with the requirements of the protocol
  • Female subjects of child-bearing potential must be willing to use reliable contraception from Visit 1 through the follow-up visit (Day 70)

Exclusion Criteria:

  • Suspicion of Crohn's disease, indeterminate colitis, microscopic colitis, segmental colitis associated with diverticulosis, ischemic colitis, or radiation-induced colitis based on medical history, endoscopy, and/or histological findings
  • Presence of infectious colitis as evidenced by positive stool culture for enteric pathogens or positive stool Clostridium difficile cytotoxin assay at Visit 1
  • Presence of chronic liver disease, with the exception of known Gilbert's syndrome
  • A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody or HIV at Visit 1
  • Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures or compromise the subject's safety
  • History of malignant neoplasm within the past 5 years, other than localized basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ that has been resected or definitively treated with standard approaches
  • Prior diagnosis of flat colonic dysplasia or unresected raised colonic dysplasia (adenoma-like lesion or mass)
  • History of regular alcohol consumption within 6 months of the Screening (Visit 1) defined as an average weekly intake of >14 drinks (one drink is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits) or presence of recreational drug abuse or dependence
  • Known bleeding disorders
  • Bowel surgery within 12 months prior to Visit 1
  • History of colectomy or partial colectomy
  • Treatment with oral aminosalicylates at doses >4.8 g per day or aminosalicylate dose modification (except transient shift lasting up to 3 days) within 4 weeks prior to study Day -5 (Note: if on this type of treatment, the dose must remain constant throughout the study treatment period)
  • Treatment with rectal aminosalicylates at any dose within 2 weeks of study Day -5
  • Treatment with systemic or rectal corticosteroids within 4 weeks of study Day -5
  • Treatment with TNFα inhibitors or other biologics within 2 months prior to study Day -5
  • Treatment with other immunosuppressants (azathioprine or 6-mercaptopurine), if initiated within 3 months prior to study Day -5, or if changed in terms of dose within 3 months prior to study Day -5 (Note: if on this type of treatment, the dose must remain constant throughout the study treatment period)
  • Regular use of pro-biotic or prebiotic preparations within 4 weeks of study Day -5 visit
  • Regular use of non-steroidal anti-inflammatories (NSAIDS) or aspirin, except low dose (cardioprotective ≤325 mg/day) aspirin, within 7 days prior to study Day -5
  • Participation in a clinical trial and treatment with an study drug within 3 months prior to Visit 1
  • Have a clinically significant finding on a chest X-ray performed at Visit 1 or within 3 months of Visit 1
  • Have an abnormal 12-lead electrocardiogram (ECG) with one or more changes considered to be clinically significant on medical review

  • Renal or liver impairment based on laboratory values obtained at Visit 1 and defined as:

    • serum creatinine level of ≥1.4 mg/dL for females and ≥1.5 mg/dL for males, or
    • AST and/or ALT ≥2x upper limit of normal (ULN), or
    • bilirubin > 1.5xULN (an isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%)
    • Hemoglobin less than 8.5 g/dL at Visit 1
    • Have any other reason which, in the opinion of the investigator, would confound the conduct or interpretation of the study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 50mg SRT2104
Single oral administration of 50mg SRT2104 study drug will be supplied as 25 mg and 250 mg capsules and will be taken orally once daily for 56 days. SRT2104 is to be taken at approximately the same time every morning, in the fasted state. Water is permitted ad libitum. Subjects are allowed to consume liquids but should refrain from eating solid food for approximately 1 hour after dosing.
Droga: SRT2104
SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 25mg or 250 mg of micronized SRT2104 powder with no additional additives into a size 00 opaque, hard gelatin capsule. All subjects will be provided with one dosing bottle per day that contains two 25 mg or 250 mg SRT2104 capsules for oral ingestion.
Sperimentale: 500mg SRT2104
Single oral administration of 500mg SRT2104 will be taken orally once daily for 56 days. SRT2104 is to be taken at approximately the same time every morning, in the fasted state. Water is permitted ad libitum. Subjects are allowed to consume liquids but should refrain from eating solid food for approximately 1 hour after dosing.
Droga: SRT2104
SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 25mg or 250 mg of micronized SRT2104 powder with no additional additives into a size 00 opaque, hard gelatin capsule. All subjects will be provided with one dosing bottle per day that contains two 25 mg or 250 mg SRT2104 capsules for oral ingestion.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of 50 mg and 500 mg of SRT2104 after repeat dosing for up to eight weeks in subjects with mild to moderate ulcerative colitis
Lasso di tempo: 75 days
75 days
SRT2104 concentration in colonic tissue will be measured via endoscopic biopsy after repeat dosing for up to 8 weeks in subjects with mild to moderate ulcerative colitis
Lasso di tempo: 56 days
56 days

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Endoscopic scoring of colonic lesions assessed during flexible sigmoidoscopy will be used as a measure of the anti-inflammatory effect of SRT2104 after 8 weeks of treatment in subjects with mild to moderate ulcerative colitis
Lasso di tempo: 75 days
75 days
Mayo score and Partial Mayo score will be used as a measure of the anti-inflammatory effect of SRT2104 after 8 weeks of treatment in subjects with mild to moderate ulcerative colitis
Lasso di tempo: 75 days
75 days
Simple Clinical Colitis Activity Index (SCCAI) will be used as a measure of the anti-inflammatory effect of SRT2104 after 8 weeks of treatment in subjects with mild to moderate ulcerative colitis
Lasso di tempo: 75 days
75 days
Fecal calprotectin will be used as a measure of the anti-inflammatory effect of SRT2104 after 8 weeks of treatment in subjects with mild to moderate ulcerative colitis
Lasso di tempo: 75 days
75 days
Histopathologic scoring of colonic tissue biopsies obtained via flexible sigmoidoscopy will be used as a measure of the anti-inflammatory effect of SRT2104 after 8 weeks of treatment in subjects with mild to moderate ulcerative colitis
Lasso di tempo: 75 days
75 days
SRT2104 concentration in plasma will be measured after repeat dosing for up to 8 weeks in subjects with mild to moderate ulcerative colitis
Lasso di tempo: 56 days
56 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sirtris, a GSK Company

Collaboratori

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 febbraio 2012

Completamento primario (Effettivo)

18 marzo 2013

Completamento dello studio (Effettivo)

18 marzo 2013

Date di iscrizione allo studio

Primo inviato

13 ottobre 2011

Primo inviato che soddisfa i criteri di controllo qualità

13 ottobre 2011

Primo Inserito (Stima)

18 ottobre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 115951

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dati/documenti di studio

  1. Protocollo di studio
    Identificatore informazioni: 115951
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Rapporto di studio clinico
    Identificatore informazioni: 115951
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Set di dati del singolo partecipante
    Identificatore informazioni: 115951
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Piano di analisi statistica
    Identificatore informazioni: 115951
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Specifica del set di dati
    Identificatore informazioni: 115951
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Modulo di consenso informato
    Identificatore informazioni: 115951
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 115951
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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