Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469040
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2007-05-03
Brief Title:
Safety Blood Levels and Effects of GW642444
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Parallel-group 14 Day Repeat Dose Study to Investigate the Safety Tolerability Pharmacokinetics and Extra-pulmonary Pharmacodynamics of Inhaled Doses of GW642444M Formulated With Magnesium Stearate in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GW642444 the study medicine is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease COPD People with asthma and COPD suffer from breathlessness because the small tubes bronchioles that carry air in and out of the lungs become narrow We hope that the study medicine will work by relaxing the muscles in the airways and help to keep the airways open and make breathing easier The study medicine might improve on available treatments by having fewer side-effects and by working faster and for longer so that patients could take it once daily instead of twice daily
When a medicine is made into a form ready to be given to patients inactive ingredients are often added Inactive ingredients might be used to help a medicine work better to make it easier to produce the medicine or to make it easier to get an accurate dose of medicine In this study the study medicine contains the inactive ingredient magnesium stearate
We need to check that the study medicine doesnt cause problems when inhaled along with magnesium stearate So were doing this study in healthy people to find out the answers to these questions
1Do repeated once-daily doses of the study medicine cause any important side effects when inhaled along with magnesium stearate as a fine powder 2How much of the study medicine gets into the bloodstream and how long does the body take to get rid of it
When a medicine is made into a form ready to be given to patients inactive ingredients are often added Inactive ingredients might be used to help a medicine work better to make it easier to produce the medicine or to make it easier to get an accurate dose of medicine In this study the study medicine contains the inactive ingredient magnesium stearate
We need to check that the study medicine doesnt cause problems when inhaled along with magnesium stearate So were doing this study in healthy people to find out the answers to these questions
1Do repeated once-daily doses of the study medicine cause any important side effects when inhaled along with magnesium stearate as a fine powder 2How much of the study medicine gets into the bloodstream and how long does the body take to get rid of it
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None