A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-09

Study Completion Date

2007-05-16

Brief Summary

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This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.

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Detailed Description

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A single-centre, randomized, double-blind placebo-controlled, dose-ascending, cross-over study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK233705 (50, 100 and 200Âµg), formulated with the excipient magnesium stearate, in healthy volunteers.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Drug

Group Type EXPERIMENTAL

GSK233705

Intervention Type DRUG

investigational drug

Interventions

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GSK233705

investigational drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects 18-55 years old
* Non-Smokers

Exclusion Criteria

* Any subject with breathing problems.
* High blood pressure and heart abnormalities.
* Any subjects currently taking prescription and non-prescription medications.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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