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Safety, Blood Levels and Effects of GW642444

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00469040
First received: May 3, 2007
Last updated: May 31, 2012
Last verified: February 2011
History of Changes
  Purpose

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?


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Asthma
 Drug: GW642444M for 14 days
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 [ Time Frame: Repeated measures on Day 1, 7 and 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Repeated measures on Day 1, 7 and 14 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: February 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW642444M 25mcg Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days
Experimental: GW642444M 50mcg Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days
Experimental: GW642444M 100mcg Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days
Experimental: GW642444M 200mcg Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days
Experimental: GW642444M 400mcg Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469040

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7NS
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00469040     History of Changes
Other Study ID Numbers: B2C108784
Study First Received: May 3, 2007
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
GW642444,
healthy subjects
magnesium stearate,

Additional relevant MeSH terms:
Asthma
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
 Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013