NCT00887406

Study of GSK961081 in Healthy Volunteer Subjects

A Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetic Profile and Pharmacodynamics of Single and Repeat Inhaled Doses of GSK961081 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	GSK961081 15mcg SD	Single dose delivered via solution for nebulisation
DRUG	GSK961081 3mcg SD	single dose delivered via nebulsier
DRUG	GSK961081 50mcg SD	single dose delivered via solution for nebulisation
DRUG	Placebo SD	single dose via nebuliser
DRUG	GSK961081 100mcg SD	single dose delivered via solution for nebulisation
DRUG	GSK961081 200mcg SD	single dose via nebuliser
DRUG	GSK961081 300mcg SD	single dose via nebuliser
DRUG	GSK961081 100mcg RD	repeat dose via nebuliser
DRUG	GSK961081 300mcg RD	repeat dose vai nebuliser
DRUG	Placebo RD	repeat dose via nebuliser

Timeline

• Start date: 2005-11-07
• Primary completion: 2006-10-04
• Completion: 2006-10-04
• First posted: 2009-04-24
• Last updated: 2021-10-06

Locations

1 site across 1 country: United Kingdom