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This study is a randomised, double-blind, placebo-controlled, dose ascending, 3-way crossover study in healthy adult male volunteers. The primary objective of the study is to assess the pharmacokinetics of 14 days dosing of GW870086X administered via nebules formulation. The secondary objective is to assess the safety and tolerability of repeat doses of nebulised GW870086X.
GW870086X is a potent glucocorticoid agonist in human in vitro functional assays that is under development as an inhaled treatment for asthma in children. This study will determine the PK characteristics and assess the safety and tolerability of the nebules formulation of GW870086X in healthy volunteers after 14 days of dosing.
This is the first clinical study that will be assessing the nebules formulation. The purpose of this study is to ensure that the doses that have been selected have a good safety profile in line with what has been found in the previous DPI formulation studies, and to assess the PK profile after single (Day 1) and repeat dose (Day 14) to select appropriate doses for future studies with the nebules formulation. This study will also provide additional safety cover with the nebules formulation given over a longer duration than studied previously with the DPI formulation before moving into the paediatric programme. This study is designed to give at least 5-fold cover for the highest dose to be studied in future paediatric programmes. During this study cortisol production will be assessed by measuring 24 hour cortisol profile in serum and urine as well as performing an ACTH stimulation test. Two doses (5mg and 8.75mg) have been selected. These doses are 5 and 10 times higher than the anticipated maximum clinical dose. The doses have been selected to ensure sufficient safety cover in future paediatric studies as well as to confirm the absence of significant adrenal inhibition at doses that would be expected to cause complete inhibition of cortisol production with traditional steroids.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:12:18-0400
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