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Safety, Blood Levels and Effects of GW642444
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00469040
  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
Asthma
Drug: GW642444 (50, 200 & 400 mcg) for 14 days
Phase I

MedlinePlus related topics: Asthma
Drug Information available for: Magnesium Aluminum monostearate Calcium stearate n-Octadecanoic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
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

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 ]

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 ]

Enrollment: 36
Study Start Date: February 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  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, MD GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: B2C108784
Study First Received: May 3, 2007
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00469040  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Study placed in the following topic categories:
Asthma
Healthy

ClinicalTrials.gov processed this record on January 16, 2009