Last updated: 11/04/2018 04:27:09

A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.

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GSK study ID
AC2108380
See study documents
Clinicaltrials.gov ID
NCT00453687
EudraCT ID
Not applicable
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 single-centre, randomized, double-blind placebo-controlled, dose-ascending, cross-over study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK233705, formulated with the excipient magnesium stearate, in healthy volunteers
Trial description: This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, lung function (FEV1, FVC) and clinical laboratory safety tests over 24 hours.

Timeframe: over 24 hours.

Secondary outcomes:

Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters from 0 to 24 hours. Serial Specific airway conductance (sGaw) and Forced Expiratory Volume in 1 second (FEV1) measurements over 24 hours post-dose.

Timeframe: over 24 hours

Interventions:
  • Drug: GSK233705
    • Enrollment:
    12
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    This study has not been published in the scientific literature.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    darotropium bromide
    Collaborators
    Not applicable
    Study date(s)
    March 2007 to May 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Healthy male subjects 18-55 years old
    • Non-Smokers
    • Any subject with breathing problems.
    • High blood pressure and heart abnormalities.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male subjects 18-55 years old
    • Non-Smokers
    Exclusion criteria:
    • Any subject with breathing problems.
    • High blood pressure and heart abnormalities.
    • Any subjects currently taking prescription and non-prescription medications.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21225
    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
    2007-16-05

    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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    Results for study AC2108380 can be found on the GSK Clinical Study Register.
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