A Study to Investigate the Pharmacology of a Dual Pharmacophore in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT00687700|
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : August 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: GSK961081 Drug: GSK961081 matching placebo Drug: Propranolol Drug: Propranolol matching placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Study to Investigate the Relative Pharmacological Activity of Aninhaled B2-agonist/Anticholinergic Dual Pharmacophore Inhealthy Volunteers|
|Actual Study Start Date :||March 10, 2008|
|Actual Primary Completion Date :||May 27, 2008|
|Actual Study Completion Date :||May 27, 2008|
Experimental: All subjects
Eligible subjects will receive GSK961081 (400 micrograms or 1200 micrograms), GSK961081 matching placebo, propranolol (80 milligrams) and propranolol matching placebo in five treatment sessions through ten different crossover treatment sequences. There will be a washout period between treatment sessions of 7 to 14 days.
GSK961081 multidose dry powder inhaler (Diskus inhaler) will be available with dosing strengths of 400 micrograms and 1200 micrograms administered once daily in the morning.
Drug: GSK961081 matching placebo
GSK961081 matching placebo multidose dry powder inhaler (Diskus inhaler) will be available to be administered once daily in the morning.
Propranolol over encapsulated tablet will be available with dosing strengths of 40 milligrams administered orally with 240 milliliters of water.
Drug: Propranolol matching placebo
Propranolol matching placebo over encapsulated tablet will be available to be administered orally with 240 milliliters of water.
- 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. [ Time Frame: Up to 32 hours ]
- Assess safety of GSK961081 after single doses of it with&without ß blockade with propranolol as measured by specific indicators [ Time Frame: Up to 71 days ]
- Adverse events, clinical laboratory safety tests, FEV1, vital signs, 12-lead ECG parameters, blood glucose and serum potassium. [ Time Frame: Up to 71 days ]
- Propranolol and GSK961081blood levels to derive pharmacokinetics [ Time Frame: Up to 32 hours ]
- Assess systemic pharmacokinetics of GSK961081 and propranolol after single doses of both [ Time Frame: Up to 32 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687700
|GSK Investigational Site|
|Harrow, Middlesex, United Kingdom, HA1 3UJ|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|