A Study to Investigate the Pharmacology of a Dual Pharmacophore in Healthy Volunteers
This study has been completed.
Information provided by (Responsible Party):
First received: May 28, 2008
Last updated: May 31, 2012
Last verified: February 2011
Study will investigate the pharmacodynamics of a dual pharmacophore in which a combination of GSK961081 and Propanolol is used to give a total effect of bronchodilation.
Pulmonary Disease, Chronic Obstructive
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Study to Investigate the Relative Pharmacological Activity of Aninhaled B2-agonist/Anticholinergic Dual Pharmacophore Inhealthy Volunteers|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- To assess the bronchodilation of single doses of GSK961081 over 24 hours following ß blockade with the ß antagonist propranolol as measured by sGaw in healthy subjects.
Secondary Outcome Measures:
- Assess safety of GSK961081 after single doses of it with&without ß blockade with propranolol as measured by specific indicators
- Adverse events, clinical laboratory safety tests, FEV1, vital signs, 12-lead ECG parameters, blood glucose and serum potassium.
- Propranolol and GSK961081blood levels to derive pharmacokinetics
- Assess systemic pharmacokinetics of GSK961081 and propranolol after single doses of both
|Study Start Date:||March 2008|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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