The purpose of this study is to compare the effects of SB-480848 with placebo in subjects with asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
67
GSK Investigational Site
Cypress, California, United States
GSK Investigational Site
Normal, Illinois, United States
GSK Investigational Site
North Dartmouth, Massachusetts, United States
GSK Investigational Site
Spartanburg, South Carolina, United States
FEV1
Time frame: 6 hours post-dose, Days 7, 14 and 21
Methacholine challenge Amounts of certain chemicals/proteins in blood Amount of drug in the blood
Time frame: before dosing and after 21 days of dosing
Measurements of FEV1 following single doses of SB-480848 and placebo.
Measurements of PC20 on Day 21 +24hrs after dosing with SB-480848 and placebo.
Time frame: Day 21 +24hrs after dosing
Blood drug levels of SB-553253 [metabolite of SB-480848] may be assessed, as appropriate.
Urinary leukotriene concentrations after 21 days of dosing with SB-480848 and Placebo.
Time frame: after 21 days
Blood levels of LpPLA2 and CD62 concentrations over 21-day dosing period with SB-480848 and placebo
Time frame: over 21-day dosing period
Measurements of FEF25-75 and peak expiratory flow following single and repeat oral doses of SB-480848.
Assessment of vitals, ECGs, safety labs and number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings, number of subjects withdrawn due to worsening of asthma on SB- 480848 and placebo.
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GSK Investigational Site
Neu-Ulm, Bavaria, Germany
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany