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A Study of GSK573719 in Healthy Japanese Male Subjects

NCT01013974 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-08-03

No results posted yet for this study

Summary

This is a single centre, randomized, double blind, placebo controlled, single and repeat dose study to investigate the safety, tolerability, and pharmacokinetics of inhaled dose of GSK573719 with lactose and containing magnesium stearate by a novel dry powder device in healthy Japanese male subjects.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

GSK573719 250 μg

Strip 1 of the dry powder inhaler will contain GSK573719 250 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.

DRUG

GSK573719 500 μg

Strip 1 of the dry powder inhaler will contain GSK573719 500 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.

DRUG

GSK573719 1000 μg

Strips 1 and 2 of the dry powder inhaler will contain 500 μg each of GSK573719 micronized drug with lactose along with magnesium stearate. It will be available as dry off white powder for inhalation.

DRUG

GSK573719 matching Placebo

Strip 1 and 2 of the dry powder inhaler will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-05
Primary Completion
2009-12-18
Completion
2009-12-18

Countries

  • Japan

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 NCT01013974 on ClinicalTrials.gov