Clinical Trial: Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open Label, 7-day Repeat Dose Study to Evaluate the Pharmacodynamics of SB-656933-AAA in Patients With Ulcerative Colitis.

Brief Summary: This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces polymorphonuclear neutrophils (PMN) accumulation in pre-clinical models of colitis. 99m-Tc-HMPAO scintigraphy is a imaging technique which will be used in this study to observe the effect of SB656933 on the migration of PMN to inflamed tissue.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Changes from baseline to after 1 and 7 days treatment with a daily dose of SB-656933-AAA in 99mTc-HMPAO labelled leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS). [ Time Frame: 7 Days ]

Original Primary Outcome: Changes from baseline to after 1 and 7 days treatment with a daily dose of SB-656933-AAA in 99mTc-HMPAO labelled leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS).

Current Secondary Outcome: Safety and tolerability of SB-656933-AAA,amount of medicine in blood,changes from baseline to after treatment in faecal calprotectin and in induced CD11b levels in a whole blood assay,Correlation between SB-656933 blood level and 99mTc-HMPAO SPECT SAS [ Time Frame: 7 Days ]

Original Secondary Outcome: Safety and tolerability of SB-656933-AAA,amount of medicine in blood,changes from baseline to after treatment in faecal calprotectin and in induced CD11b levels in a whole blood assay,Correlation between SB-656933 blood level and 99mTc-HMPAO SPECT SAS

Information By: GlaxoSmithKline

Dates:
Date Received: September 5, 2008
Date Started: January 2009
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017