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

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ClinicalTrials.gov Identifier: NCT00453687
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: GSK233705 Phase 1

Detailed Description:
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 (50, 100 and 200µg), formulated with the excipient magnesium stearate, in healthy volunteers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 9, 2007
Actual Primary Completion Date : May 16, 2007
Actual Study Completion Date : May 16, 2007

Arm Intervention/treatment
Experimental: Arm 1
Drug
Drug: GSK233705
investigational drug




Primary Outcome Measures :
  1. 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. [ Time Frame: over 24 hours. ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: over 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453687


Locations
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United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AC2108380
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: AC2108380
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AC2108380
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: AC2108380
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: AC2108380
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: AC2108380
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: AC2108380
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
This study has not been published in the scientific literature.

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00453687     History of Changes
Other Study ID Numbers: AC2108380
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
COPD
GSK233705,
Magnesium Stearate,

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive