GSK159802 In Healthy Male Subjects And Asthmatics
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Asthma
Eligibility Criteria
Inclusion criteria: Body mass index within the range 18.5-29.9 (kg/m2) Current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years. Additional criteria for Cohorts 2 and 3 only (Asthmatic Patients): Subjects with a documented history of mild to moderate asthma, with the exclusion of other significant pulmonary disease Subjects with clinically stable asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 greater than 60% and less than 90% predicted. During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of > or equal to 12.0% over baseline and an absolute change of > or equal to 300 mL within 30 minutes following 400 mcg salbutamol. Exclusion criteria: Any clinically relevant abnormality Subjects who have a screening haemoglobin values < 11 g/dL The subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 112 days or a clinical study with any other drug during the previous 84 days Subjects with known hypersensitivity to salmeterol or salbutamol or any ingredients in their preparations.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Subjects receiving treatment sequence 1 : Cohort 1
Subjects receiving treatment sequence 2 : Cohort 1
Subjects receiving treatment sequence 3 : Cohort 1
Subjects receiving treatment sequence 4 : Cohort 1
Subjects receiving treatment sequence 5 : Cohort 1
Subjects receiving treatment sequence 1 : Cohort 2
Subjects receiving treatment sequence 2 : Cohort 2
Subjects receiving treatment sequence 3 : Cohort 2
Subjects receiving treatment sequence 4 : Cohort 2
Subjects receiving treatment sequence 1 : Cohort 3
Subjects receiving treatment sequence 2 : Cohort 3
Subjects receiving treatment sequence 3 : Cohort 3
Subjects receiving treatment sequence 4 : Cohort 3
Subjects receiving treatment sequence 5 : Cohort 3
Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.