Last updated: 11/04/2018 05:37:16

Safety, blood levels and effects of GW642444

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GSK study ID
B2C108784
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Clinicaltrials.gov ID
NCT00469040
EudraCT ID
2006-005814-10
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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?
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Repeated measures on Day 1, 7 and 14

Secondary outcomes:

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

Timeframe: Repeated measures on Day 1, 7 and 14

Interventions:
  • Drug: GW642444M for 14 days
    • Enrollment:
    36
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013;26(2):256-64.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    vilanterol
    Collaborators
    Not applicable
    Study date(s)
    February 2007 to April 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • healthy males and females (of non-childbearing potential) aged 18-55
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, NW10 7NS
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-16-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
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