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A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male subjects
Liver function tests normal
18 - 45 years old
Can provide written informed consent
Available to complete the whole trial
Can use the inhalation device correctly
Able to read, understand and write English
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