Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Single-centre, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerabilty, Pharmacokinetics, and Pharmacodynamics of Single, Oral, Ascending Doses and Repeat Oral Doses of GSK1325756 in Healthy Male Subjects.
This study aims to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single, oral ascending doses, and repeat oral doses of GSK1325756 administered to healthy adult male volunteers. This study is the First Time in Human study for GSK1325756.
This study will evaluate the safety, tolerability, pharmacokinetics(PK) and pharmacodynamics
(PD) of single and repeat oral doses of GSK1325756 in healthy, male volunteer subjects,
including the assessment of the effect of GSK1325756 on ex vivo 'C-X-C Motif Ligand 1'
(CXCL1)-induced 'Cluster of Differentiation 11b' (CD11b) cell surface expression on
peripheral blood neutrophils. Selective antagonism of the interaction between 'C-X-C
Receptor Type 2' (CXCR2) and its various chemokine ligands provides a potential strategy for
reducing the underlying inflammation that contributes to the progression of Chronic
Obstructive Pulmonary Disease (COPD). This study is the first administration of GSK1325756
to humans and will be conducted in four cohorts.
Cohorts 1 and 2 will comprise of a double-blind, placebo-controlled, single dose escalation
of GSK132576 in healthy adult males in two interlocking cohorts.
The data generated from this single dose escalation component of the study (safety,
tolerability, and where applicable, PK profile, and, if available, PD data) will enable
decisions regarding progression from one to dose the next higher dose later within Cohorts 1
and 2. This data will also be reviewed in decisions regarding study progression to repeat
dosing in Cohorts 3 and 4, and the most suitable doses of GSK1325756 that should be selected
for these repeat dose cohorts.
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