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Study of GSK961081 in Healthy Volunteer Subjects

NCT00887406 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-10-06

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-07
Primary Completion
2006-10-04
Completion
2006-10-04

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887406 on ClinicalTrials.gov