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Completed

NCT Number: NCT00469040

Safety, Blood Levels and Effects of GW642444

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?

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

London, NW10 7NS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW642444M for 14 days

Drug

M salt

Other names: GW642444 (25, 50, 100, 200 & 400 mcg) for 14 days

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 4, 2007
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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