A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers

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

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.

Inclusion criteria:

• Healthy male subjects
• Liver function tests normal
• 18 - 45 years old
• Non smoker
• Can provide written informed consent
• Available to complete the whole trial
• Can use the inhalation device correctly
• Able to read, understand and write English

Exclusion criteria:

• Deemed suitable healthy subject
• History to sensitivity to the study medication
• Any history of breathing problems in adult life
• Participated in another trial within 30 days or 5 half-lives of the new chemical entity
• Exposed to more than 4 new chemical entities within 12 months
• Donated >500 mL blood within 2 months of screening
• Haemoglobin level < 13g/dl
• Use of prescription or non-prescription drugs within 7 days of first dose
• Taking drugs that significantly inhibit cytochrome P450 subfamily enzyme CYP3A4
• Drinks more than 4 units a day or 28 units a week
• Cannot use DISKHALER device correctly
• Positive HepB, HepC within 3 months of screening
• Positive HIV test
• Positive pre study drug/alcohol screen
• Significant cardiac conduction abnormalities
• Risk of non-compliance