Back to resultsA Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK233705
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, GSK233705,, Magnesium Stearate,
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Drug
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00453687
Brief Title
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 9, 2007 (Actual)
Primary Completion Date
May 16, 2007 (Actual)
Study Completion Date
May 16, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD, GSK233705,, Magnesium Stearate,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Drug
Intervention Type
Drug
Intervention Name(s)
GSK233705
Intervention Description
investigational drug
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
Citation
This study has not been published in the scientific literature.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2108380
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2108380
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2108380
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2108380
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2108380
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2108380
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2108380
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.
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