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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: GSK233705

Study type: Interventional

Funder types: Industry

Identifiers

NCT00453687

AC2108380

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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12 participants in 1 patient group

Arm 1

Experimental group

Description:

Drug

Treatment:

Drug: GSK233705