GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids but is also less potent. This study will look at higher doses to confirm the improved safety profile.
A randomized, double-blind, placebo-controlled, dose ascending, 3-cohort parallel group study to measure the systemic cortisol profile and evaluate the safety, tolerability and pharmacokinetics of GW870086X, administered as single doses (12mg and 15mg),and repeat doses over 3 days (6mg, 12mg and 15mg) in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
GSK Investigational Site
Herston, Queensland, Australia
Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing
Time frame: 3 days
Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function
Time frame: 3 days
Total urinary free cortisol excretion
Time frame: over 24 hours on Day 1 and Day 3.
Serum osteocalcin weighted mean
Time frame: over 24 hours on Day 3.
Fasting glucose
Time frame: on Day 1
mRNA steroid responsive gene panel
Time frame: 3 days
Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax).
Time frame: 3 days
Plasma concentrations of GW870086X and derived pharmacokinetic parameters
Time frame: 3 days
Cortsiol urine concentrations
Time frame: 3 days
Osteocalcin serum concentrations
Time frame: 3 days
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