Safety, Blood Levels and Effects of GW642444

Study Overview
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Brief Summary
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GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. We hope that the study medicine will work by relaxing the muscles in the airways and help to keep the airways open, and make breathing easier. The study medicine might improve on available treatments by having fewer side-effects, and by working faster and for longer, so that patients could take it once daily, instead of twice daily. When a medicine is made into a form ready to be given to patients, inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In this study, the study medicine contains the inactive ingredient magnesium stearate. We need to check that the study medicine doesn't cause problems when inhaled along with magnesium stearate. So, we're doing this study in healthy people to find out the answers to these questions. 1)Do repeated once-daily doses of the study medicine cause any important side effects when inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine gets into the bloodstream and how long does the body take to get rid of it?

Official Title
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A Randomised, Double-blind, Placebo-controlled, Parallel-group, 14 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Extra-pulmonary Pharmacodynamics of Inhaled Doses of GW642444M Formulated With Magnesium Stearate in Healthy Subjects

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: GW642444M for 14 days


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: healthy males and females (of non-childbearing potential) aged 18-55 body weight >50kg with BMI 19-29.9 kg/m2 normal ECG recording non-smoker Exclusion criteria: high blood pressure (above 140/90 mmHg) pulse outside range 45 - 90 bpm history of breathing problems e.g. asthma low haemoglobin (<11 g/dL) blood donation within 56 days of study start taking regular medication participation in another trial within 4 months of study start history of drug or alcohol abuse abnormal clinical laboratory tests known allergies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GW642444M 25mcg<br>In Cohort 1 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 25 mcg. | Drug: GW642444M for 14 days<br>* M salt<br>* Other names: 200 & 400 mcg) for 14 days;|
| Experimental: GW642444M 50mcg<br>Subjects after randomization will receive two inhalations of 25 mcg GW642444M in Cohort 1. | Drug: GW642444M for 14 days<br>* M salt<br>* Other names: 200 & 400 mcg) for 14 days;|
| Experimental: GW642444M 100mcg<br>In Cohort 2 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 100 mcg. | Drug: GW642444M for 14 days<br>* M salt<br>* Other names: 200 & 400 mcg) for 14 days;|
| Experimental: GW642444M 200mcg<br>Subjects after randomization will receive two inhalations of 100 mcg GW642444M in Cohort 2. | Drug: GW642444M for 14 days<br>* M salt<br>* Other names: 200 & 400 mcg) for 14 days;|
| Experimental: GW642444M 400mcg<br>Subjects after randomization will receive two inhalations of 200 mcg GW642444M in Cohort 3. | Drug: GW642444M for 14 days<br>* M salt<br>* Other names: 200 & 400 mcg) for 14 days;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General safety and tolerability as measured by ECG, blood pressure, pulse rate and blood and urine tests. Repeated measures on Day 1, 7 and 14 |  | Repeated measures on Day 1, 7 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of the medicine on the body as measured by potassium and glucose levels in the blood. Monitoring of the study medicine in the body by analysis of blood samples. Repeated measures on Day 1, 7 and 14 |  | Repeated measures on Day 1, 7 and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GW642444,, healthy subjects, magnesium stearate,