A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
GSK573719
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring muscarinic receptor antagonist, GSK573719,, chronic obstructive pulmonary disease,
Eligibility Criteria
Inclusion criteria:
- Healthy Caucasian male subjects or healthy Caucasian female subjects of non-childbearing potential
- Aged between 18-55 years
- Non-smokers
- Normal spirometry (FEV1 = 80% of predicted, FEV1/FVC = 70%)
- A signed and dated written informed consent is obtained from the subject
- The subject is capable of giving informed consent
- Available to complete the study
- Subject has a BMI within the range 18.0-30.0kg/m2 inclusive
Exclusion criteria:
- Any clinically important abnormality identified at the screening medical assessment
- A history of breathing problems
- A mean QTc(B) value at screening >450msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, or an ECG that is not suitable for QT measurements
- A history of elevated resting blood pressure or a mean blood pressure equal to or higher than 140/90 mmHg at screening
- A mean heart rate outside the range 40-90 bpm at screening
- History of use of tobacco products within 6 months of screening, or positive urine cotinine at screening
- Subjects with a 2D6 poor metabolizer genotype (Caucasian)
- The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study
- The subject is currently taking regular (or course of) medication, whether prescribed or not
- The subject has taken prescription medications within the past 2 weeks prior to dosing or OTC medications within 48 hours prior to dosing
- The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior to dosing
- The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
- The subject has a positive pre-study drug screen
- The subject has a positive pre-study alcohol screen
- The subject has a suspected history of alcohol abuse within the six months previous to the screening visit
- The subject is unable to use the DISKUS
- The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives
- The subject has a known allergy or hypersensitivity to milk protein or the excipient lactose monohydrate
- Subjects who might have prostatic hypertrophy, bladder outlet obstruction, or narrow angle glaucoma
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, Holter and Lead II ECG monitoring, lung function and clinical laboratory safety tests throughout the study
Secondary Outcome Measures
- Ambulatory blood pressure for repeat dosing - 24hr Holter monitoring for repeat dosing - Plasma and urine concentrations of GSK573719 and derived pharmacokinetic parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00475436
Brief Title
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers
Official Title
A Single-centre, Randomised, Double-blind, Placebo-controlled, Dose-ascending, 3-cohort Parallel-group Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK573719 Administered as Singledoses (750 μg and 1000 μg) and Repeat Doses Over 14 Days (250 μg-1000 μg Once-daily) of GSK573719 in Healthy Male and Female Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 14, 2007 (Actual)
Primary Completion Date
September 18, 2007 (Actual)
Study Completion Date
September 18, 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
GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for COPD
Detailed Description
A single-centre, randomised, double-blind, placebo-controlled, dose-ascending, 3-cohort parallel-group study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GSK573719 administered as single doses (750µg and 1000µg) and repeat doses over 14 days (250µg-1000µg once-daily) of GSK573719 in healthy male and female subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
muscarinic receptor antagonist, GSK573719,, chronic obstructive pulmonary disease,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GSK573719
Primary Outcome Measure Information:
Title
General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, Holter and Lead II ECG monitoring, lung function and clinical laboratory safety tests throughout the study
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
- Ambulatory blood pressure for repeat dosing - 24hr Holter monitoring for repeat dosing - Plasma and urine concentrations of GSK573719 and derived pharmacokinetic parameters
Time Frame
throughout the study
10. Eligibility
Sex
All
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 Caucasian male subjects or healthy Caucasian female subjects of non-childbearing potential
Aged between 18-55 years
Non-smokers
Normal spirometry (FEV1 = 80% of predicted, FEV1/FVC = 70%)
A signed and dated written informed consent is obtained from the subject
The subject is capable of giving informed consent
Available to complete the study
Subject has a BMI within the range 18.0-30.0kg/m2 inclusive
Exclusion criteria:
Any clinically important abnormality identified at the screening medical assessment
A history of breathing problems
A mean QTc(B) value at screening >450msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, or an ECG that is not suitable for QT measurements
A history of elevated resting blood pressure or a mean blood pressure equal to or higher than 140/90 mmHg at screening
A mean heart rate outside the range 40-90 bpm at screening
History of use of tobacco products within 6 months of screening, or positive urine cotinine at screening
Subjects with a 2D6 poor metabolizer genotype (Caucasian)
The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study
The subject is currently taking regular (or course of) medication, whether prescribed or not
The subject has taken prescription medications within the past 2 weeks prior to dosing or OTC medications within 48 hours prior to dosing
The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior to dosing
The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
The subject has a positive pre-study drug screen
The subject has a positive pre-study alcohol screen
The subject has a suspected history of alcohol abuse within the six months previous to the screening visit
The subject is unable to use the DISKUS
The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives
The subject has a known allergy or hypersensitivity to milk protein or the excipient lactose monohydrate
Subjects who might have prostatic hypertrophy, bladder outlet obstruction, or narrow angle glaucoma
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
Berlin
ZIP/Postal Code
14050
Country
Germany
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:
PubMed Identifier
23784369
Citation
Cahn A, Tal-Singer R, Pouliquen IJ, Mehta R, Preece A, Hardes K, Crater G, Deans A. Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects: two randomized studies. Clin Drug Investig. 2013 Jul;33(7):477-88. doi: 10.1007/s40261-013-0088-7.
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
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC4106889
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
AC4106889
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC4106889
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
AC4106889
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
AC4106889
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
AC4106889
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
AC4106889
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 GSK573719 In Healthy Volunteers
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