Safety, Blood Levels and Effects of GW642444

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: GW642444M for 14 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00469040

B2C108784

Details and patient eligibility

About

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?

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 5 patient groups

GW642444M 25mcg

Experimental group

Description:

In Cohort 1 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 25 mcg.

Treatment:

Drug: GW642444M for 14 days

GW642444M 50mcg

Experimental group

Description:

Subjects after randomization will receive two inhalations of 25 mcg GW642444M in Cohort 1.

Treatment:

Drug: GW642444M for 14 days

GW642444M 100mcg

Experimental group

Description:

In Cohort 2 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 100 mcg.

Treatment:

Drug: GW642444M for 14 days

GW642444M 200mcg

Experimental group

Description:

Subjects after randomization will receive two inhalations of 100 mcg GW642444M in Cohort 2.

Treatment:

Drug: GW642444M for 14 days

GW642444M 400mcg

Experimental group

Description:

Subjects after randomization will receive two inhalations of 200 mcg GW642444M in Cohort 3.

Treatment:

Drug: GW642444M for 14 days