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

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: GSK233705

• Registration Number: NCT00453687
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

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 200µg), formulated with the excipient magnesium stearate, in healthy volunteers.

Study Timeline

• Study Start: 2007-03-09
• Study First Submitted: 2007-03-27
• Study First Submitted QC: 2007-03-28
• Study First Posted: 2007-03-29
• Primary Completion: 2007-05-16
• Study Completion: 2007-05-16
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	GSK233705	Drug

Primary Outcome Measures

Name	Time	Method
General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, lung function (FEV1, FVC) and clinical laboratory safety tests over 24 hours.	over 24 hours.

Secondary Outcome Measures

Name	Time	Method
Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters from 0 to 24 hours. Serial Specific airway conductance (sGaw) and Forced Expiratory Volume in 1 second (FEV1) measurements over 24 hours post-dose.	over 24 hours

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Baltimore, Maryland, United States