Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00887406 |
GSK961081 is a new long-acting bronchodilator being developed for the treatment of chronic obstructive pulmonary disease (COPD). This study is the first clinical study in humans. The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK961081 in healthy male subjects.
Condition | Intervention | Phase |
---|---|---|
Healthy Subjects |
Drug: GSK961081 50mcg SD Drug: GSK961081 200mcg SD Drug: GSK961081 300mcg SD Drug: Placebo SD Drug: GSK961081 300mcg RD Drug: Placebo RD Drug: GSK961081 100mcg RD Drug: GSK961081 100mcg SD Drug: GSK961081 15mcg SD Drug: GSK961081 3mcg SD |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetic Profile and Pharmacodynamics of Single and Repeat Inhaled Doses of GSK961081 in Healthy Subjects |
Enrollment: | 46 |
Study Start Date: | November 2005 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort 1, Period 2: Experimental
GSK961081 3mcg, Placebo, GSK961081 15mcg, GSK961081 50mcg
|
Drug: GSK961081 50mcg SD
single dose delivered via solution for nebulisation
Drug: Placebo SD
single dose via nebuliser
Drug: GSK961081 15mcg SD
Single dose delivered via solution for nebulisation
Drug: GSK961081 3mcg SD
single dose delivered via nebulsier
|
Cohort 2, period 3: Experimental
GSK961081 100mcg, GSK961081 200mcg, Placebo, GSK961081 300mcg
|
Drug: GSK961081 200mcg SD
single dose via nebuliser
Drug: GSK961081 300mcg SD
single dose via nebuliser
Drug: Placebo SD
single dose via nebuliser
Drug: GSK961081 100mcg SD
single dose delivered via solution for nebulisation
|
Cohort 1, period 4: Experimental
GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg, Placebo
|
Drug: GSK961081 50mcg SD
single dose delivered via solution for nebulisation
Drug: Placebo SD
single dose via nebuliser
Drug: GSK961081 15mcg SD
Single dose delivered via solution for nebulisation
Drug: GSK961081 3mcg SD
single dose delivered via nebulsier
|
Cohort 2, period 4: Experimental
GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, Placebo
|
Drug: GSK961081 200mcg SD
single dose via nebuliser
Drug: GSK961081 300mcg SD
single dose via nebuliser
Drug: Placebo SD
single dose via nebuliser
Drug: GSK961081 100mcg SD
single dose delivered via solution for nebulisation
|
Cohort 1, period 3: Experimental
GSK961081 3mcg, GSK961081 15mcg, Placebo, GSK961081 50mcg
|
Drug: GSK961081 50mcg SD
single dose delivered via solution for nebulisation
Drug: Placebo SD
single dose via nebuliser
Drug: GSK961081 15mcg SD
Single dose delivered via solution for nebulisation
Drug: GSK961081 3mcg SD
single dose delivered via nebulsier
|
Cohort 1, period 1: Experimental
Placebo, GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg
|
Drug: GSK961081 50mcg SD
single dose delivered via solution for nebulisation
Drug: Placebo SD
single dose via nebuliser
Drug: GSK961081 15mcg SD
Single dose delivered via solution for nebulisation
Drug: GSK961081 3mcg SD
single dose delivered via nebulsier
|
Cohort 2, period 1: Experimental
Placebo, GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg,
|
Drug: GSK961081 200mcg SD
single dose via nebuliser
Drug: GSK961081 300mcg SD
single dose via nebuliser
Drug: Placebo SD
single dose via nebuliser
Drug: GSK961081 100mcg SD
single dose delivered via solution for nebulisation
|
Cohort 3: Experimental
GSK961081 100mcg or Placebo
|
Drug: Placebo RD
repeat dose via nebuliser
Drug: GSK961081 100mcg RD
repeat dose via nebuliser
|
Cohort 2, period 2: Experimental
GSK961081 100mcg, Placebo, GSK961081 200mcg, GSK961081 300mcg
|
Drug: GSK961081 200mcg SD
single dose via nebuliser
Drug: GSK961081 300mcg SD
single dose via nebuliser
Drug: Placebo SD
single dose via nebuliser
Drug: GSK961081 100mcg SD
single dose delivered via solution for nebulisation
|
Cohort 4: Experimental
GSK961081 300mcg or Placebo
|
Drug: GSK961081 300mcg RD
repeat dose vai nebuliser
Drug: Placebo RD
repeat dose via nebuliser
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104865, MAB104865 |
Study First Received: | April 23, 2009 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00887406 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
COPD long-acting bronchodilator first time in human study |
Healthy Bronchodilator Agents |