Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

Study Overview
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Brief Summary
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This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. Male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will be a wash-out period of at least 5 days between doses.

Official Title
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A Double-blind, Placebo-controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Dose Dry Powder GW685698X Containing Magnesium Stearate in Subjects With Mild to Moderate Asthmatic Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: GW685698X
* Drug: GW685698X containing magnesium stearate


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit, screening pre-bronchodilator FEV1 >or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of >or= 12.0% over the max of the three screening measures and an absolute change of >or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria), BMI 19-31 kg/m2, Non-smoker, refrains from use of prohibited medication within the specified timeframes Exclusion criteria: Pregnant or nursing females History of life threatening asthma Subjects who are unable to stop taking protocol defined prohibited medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>Subjects will receive GW685698X 800 microgram (mcg) single inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. | Drug: GW685698X<br>* GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS<br>Drug: GW685698X containing magnesium stearate<br>* GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS<br>|
| Experimental: Treatment 2<br>Subjects will receive GW685698X 800 mcg containing magnesium stearate inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. | Drug: GW685698X<br>* GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS<br>Drug: GW685698X containing magnesium stearate<br>* GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days |  | Vital signs: for 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma GW685698X concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) following single inhaled doses in mild/moderate asthmatic patients for 48 hours. Weighted mean serum cortisol (0-24 h) on Day 1. |  | following single inhaled doses in mild/moderate asthmatic patients for 48 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthmatic Patients