The purpose of this study is to describe the safety and tolerability of single and repeat oral doses of GSK1440115 in healthy volunteers.
This study is the first administration of GSK1440115 to humans. GSK1440115 is a urotensin II receptor antagonist which is being developed for the treatment of asthma. This will be a two-part study to evaluate the safety, tolerability, and pharmacokinetics of single (Part A) and repeat (Part B) oral doses of GSK1440115 in healthy adult male and female (of non-child bearing potential) subjects. This study will be a randomized, single-blind, placebo-controlled, dose escalation design. Part A will evaluate a single dose of GSK1440115. Part B will evaluate repeat daily doses for 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Investigational Site
Melbourne, Australia
Safety and tolerability assessments consisting of Adverse Events, ECGs, vital signs, clinical observations, and clinical laboratory tests
Time frame: Throughout study
Plasma drug concentration versus time curve [AUC (0-t), AUC [0-∞], AUC(0-t)], maximum Cmax, tmax, and t1/2 of GSK1140115 as data permit
Time frame: Duration of dosing
Blood pressure (BP) and heart rate (HR)
Time frame: Duration of dosing
Peak expiratory flow rate (PEFR)
Time frame: Duration of Dosing
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