The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic impairment and in healthy subjects following a single oral inhaled dose of GW685698X. From the study results it should be possible to assess if there is an altered Risk: Benefit in patients with moderate hepatic impairment
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.
To investigate how impaired liver function affects the movement of single dose inhaled drug GW685698X within the body. Blood exposure levels in patients and matched control patients compared by taking blood samples after dosing
Time frame: Up to Day 13
Effect of GW685698X on serum cortisol by calculating weighted mean in blood over 24 hrs. Safety and tolerability of GW685698X in patients with impaired liver function from blood samples during dosing (clearance/distribution) and monitoring vital signs
Time frame: Up to Day 13
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.