A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
100mcg
500mcg
1000mcg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Healthy volunteers, New formulation
Eligibility Criteria
Inclusion Criteria:
- Healthy.
- Male or female 18 to 65 years of age inclusive.
- Non-childbearing women or women of child bearing potential who agree to use contraception
- Subject has had their CYP2D6 genotype confirmed and can be included in either of the following parts:
- Part 1: may include extensive, intermediate and ultra-rapid metabolizers
- Part 2: includes only poor (no enzyme activity) metabolizers, with previously confirmed phenotype
- Body Mass Index within the range 18 - 30 kg/m2 (inclusive).
- Capable of giving written informed consent
- Normal ECG;
- Normal lung function.
- Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked))
- 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
Exclusion Criteria:
- Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead). 24hr Holter monitoring outside normal limits.
- A history of breathing problems (i.e. history of asthmatic symptomatology).
- Abnormal ECG.
- Abnormal blood pressure.
- Abnormal heart rate
- The subject has a positive pre-study drug/alcohol screen.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three months of screening.
- A positive test for HIV antibody (if determined by the local SOPs).
- History of high alcohol consumption within three months of the study
- The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the IP (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, (except for simple analgesics e.g. paracetamol), including vitamins, herbal and dietary supplements (including St John's Wort) within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to the first dose of study medication
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products prior to screening.
- The subject is unable to use the novel dry powder inhaler correctly.
- The subject has a known allergy or hypersensitivity to milk protein or the excipients magnesium stearate and lactose monohydrate.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Active
Active 2
Active 3
Placebo
Arm Description
100mcg 719
500mcg '719
1000mcg '719
Placebo '719
Outcomes
Primary Outcome Measures
General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests
Secondary Outcome Measures
Blood and urine levels of study drug
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00803673
Brief Title
A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
Official Title
A Single Centre, Randomized, Double-blind, Dose Ascending, Placebo-controlled Study, in Two Parts, to Evaluate the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Inhaled Doses of GSK573719 and Placebo Formulated With the Excipient Magnesium Stearate, in Healthy Subjects and in a Healthy Population of Cytochrome P450 Isoenzyme 2D6 Poor Metabolisers.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 5, 2008 (Actual)
Primary Completion Date
October 16, 2008 (Actual)
Study Completion Date
October 16, 2008 (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 is to look at a new formulation of GSK573719 to see if it is safe and tolerated 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
Healthy volunteers, New formulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
100mcg 719
Arm Title
Active 2
Arm Type
Experimental
Arm Description
500mcg '719
Arm Title
Active 3
Arm Type
Experimental
Arm Description
1000mcg '719
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo '719
Intervention Type
Drug
Intervention Name(s)
100mcg
Intervention Description
100mcg '719
Intervention Type
Drug
Intervention Name(s)
500mcg
Intervention Description
500mcg '719
Intervention Type
Drug
Intervention Name(s)
1000mcg
Intervention Description
1000mcg '719
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo '719
Primary Outcome Measure Information:
Title
General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests
Time Frame
Various
Secondary Outcome Measure Information:
Title
Blood and urine levels of study drug
Time Frame
various
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy.
Male or female 18 to 65 years of age inclusive.
Non-childbearing women or women of child bearing potential who agree to use contraception
Subject has had their CYP2D6 genotype confirmed and can be included in either of the following parts:
Part 1: may include extensive, intermediate and ultra-rapid metabolizers
Part 2: includes only poor (no enzyme activity) metabolizers, with previously confirmed phenotype
Body Mass Index within the range 18 - 30 kg/m2 (inclusive).
Capable of giving written informed consent
Normal ECG;
Normal lung function.
Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked))
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
Exclusion Criteria:
Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead). 24hr Holter monitoring outside normal limits.
A history of breathing problems (i.e. history of asthmatic symptomatology).
Abnormal ECG.
Abnormal blood pressure.
Abnormal heart rate
The subject has a positive pre-study drug/alcohol screen.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three months of screening.
A positive test for HIV antibody (if determined by the local SOPs).
History of high alcohol consumption within three months of the study
The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the IP (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Use of prescription or non-prescription drugs, (except for simple analgesics e.g. paracetamol), including vitamins, herbal and dietary supplements (including St John's Wort) within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to the first dose of study medication
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.
Unwillingness or inability to follow the procedures outlined in the protocol.
Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products prior to screening.
The subject is unable to use the novel dry powder inhaler correctly.
The subject has a known allergy or hypersensitivity to milk protein or the excipients magnesium stearate and lactose monohydrate.
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
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
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
23881566
Citation
Cahn A, Mehta R, Preece A, Blowers J, Donald A. Safety, tolerability and pharmacokinetics and pharmacodynamics of inhaled once-daily umeclidinium in healthy adults deficient in CYP2D6 activity: a double-blind, randomized clinical trial. Clin Drug Investig. 2013 Sep;33(9):653-64. doi: 10.1007/s40261-013-0109-6.
Results Reference
derived
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
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110106
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
110106
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
110106
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
110106
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
110106
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
110106
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
110106
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
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