A Randomised, Double Blind, Placebo Controlled Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Profile of Single Inhaled Dry Powder Doses of GSK159802 in Healthy Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Safety & tolerability of single inhaled doses of GSK159802.
Study Overview
Brief Summary
GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which is being developed for once daily treatment of asthma and COPD as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are limited by local administration and also tend to show tachyphylaxis.
The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily administration, given their duration of action. Therefore, there is significant opportunity for a once-daily inhaled medication to improve patient compliance and overall disease management by providing sustained, 24-hour bronchodilation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Subjects receiving treatment sequence 1 : Cohort 1
Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 1 : Cohort 1
Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 1 : Cohort 1
Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 2 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 2 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 2 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 3 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 3 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 3 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 4 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 4 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 4 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 5 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 5 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 5 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 1 : Cohort 2
Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 1 : Cohort 2
Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 1 : Cohort 2
Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 2 : Cohort 2
Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 2 : Cohort 2
Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 2 : Cohort 2
Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 3 : Cohort 2
Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 3 : Cohort 2
Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 3 : Cohort 2
Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 4 : Cohort 2
Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 4 : Cohort 2
Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 4 : Cohort 2
Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 1 : Cohort 3
Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 1 : Cohort 3
Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 1 : Cohort 3
Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 2 : Cohort 3
Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 2 : Cohort 3
Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 2 : Cohort 3
Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 3 : Cohort 3
Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 3 : Cohort 3
Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 3 : Cohort 3
Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 4 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 4 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 4 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
Intervention: Salmeterol (Drug)
Subjects receiving treatment sequence 5 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.
Intervention: GSK159802 (Drug)
Subjects receiving treatment sequence 5 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.
Intervention: Placebo (Drug)
Subjects receiving treatment sequence 5 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.
Intervention: Salmeterol (Drug)
Outcomes
Primary Outcomes
Safety & tolerability of single inhaled doses of GSK159802.
Time Frame: Up to 71 days
Secondary Outcomes
- sGaw (Cohorts 1 and 2 only) and FEV1 Systemic & urine pharmacokinetics of GSK159802 and SKF-91300 Heart rate, potassium, glucose, 12-lead ECG & blood pressure(Up to 71 days)