A Study of Repeat Inhaled Doses of GW642444M in Healthy Japanese Male Subjects

This study is not yet open for participant recruitment.

Verified by GlaxoSmithKline, September 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00753701

Purpose

This study will investigate the the safety, tolerability, pharmacokinetics, and pharmacodynamic of inhaled doses of GW642444M in Japanese healthy male subject.

Condition	Intervention	Phase
Asthma COPD	Drug: GW642444	Phase I

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	Phase I Study of GW642444M - A Randomized, Double Blind, Placebo Controlled, Parallel-Group, 7 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Dose of GW642444M From a Novel Dry Powder Device in Healthy Japanese Male Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Safety/tolerability of repeat inhaled doses of GW642444M

Secondary Outcome Measures:

Pharmacokinetic parameters of GW642444
Pharmacodynamics parameters of the systemic ß-adreneric effects

Estimated Enrollment:	32
Study Start Date:	September 2008

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Japanese healthy male volunteers
Body weight not lower than 50kg and BMI within 18.5-25.0kg/m2
Non-smokers

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753701

Locations

Japan
GSK Clinical Trials Call Center
Fukuoka, Japan, 812

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Study ID Numbers:	DB1112017
Study First Received:	September 12, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00753701
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

GW642444
healthy Japanese subject
safety and tolerability
pharmacokinetics

Study placed in the following topic categories:

Asthma
Healthy

ClinicalTrials.gov processed this record on January 16, 2009