Phase I Study of GSK233705 in Healthy Japanese Male Subjects
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
GSK233705
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests.
- Body weight ≥ 50kg and BMI within the range 18.50-25.00kg/m2 inclusive.
- 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))
- Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).
Clinical laboratory tests data obtained at screening meet the following:
AST(GOT), ALT(GPT), total-bilirubin: below the upper limit of the normal ranges
- Normal 12-lead EGC finding at screening; QTc interval <450msec
- A mean blood pressure lower than 140/90mmHg at screening.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Capable of using the novel dry powder inhaler.
Exclusion Criteria:
- The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
- The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
- The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
- A history of breathing problems (i.e. history of asthmatic symptomatology, asthma in childhood).
- The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium, atropine and any of its derivatives.
- The subject has a known allergy or hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate.
- The subject has a history or current conditions of drug abuse or alcoholism.
- History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink=5 ounces (150mL) of wine or 350mL of beer or 1.5 ounces (45mL) of 80 proof distilled spirits) within 6 month of screening.
- The subject is positive for urine drug screening.
- The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
- The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" within the previous 1 month.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LAMA
Placebo
Arm Description
After randomization subject will inhale either GSK233705 50, 100 or 200 microgram once daily for 7 days.
After randomization subjects will inhale placebo once daily for 7 days.
Outcomes
Primary Outcome Measures
Safety:adverse events, vital sign, ECGs, and clinical laboratory test
PK:Cmax, tmax and AUC(0-t)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00964405
Brief Title
Phase I Study of GSK233705 in Healthy Japanese Male Subjects
Official Title
Phase I Study of GSK233705- A Randomised, Double Blind, Placebo-controlled, 2-parts Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Inhaled Doses of GSK233705 From a Novel Dry Powder Device in Healthy Japanese Male Subjects -
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 20, 2008 (Actual)
Primary Completion Date
December 20, 2008 (Actual)
Study Completion Date
December 20, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This is a randomised, double blind, placebo-controlled, 2-parts study to investigate the safety, tolerability, and pharmacokinetics of single and repeat inhaled doses of GSK233705 from a novel dry powder device in healthy Japanese male subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAMA
Arm Type
Experimental
Arm Description
After randomization subject will inhale either GSK233705 50, 100 or 200 microgram once daily for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
After randomization subjects will inhale placebo once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
GSK233705
Intervention Description
Inhaled Long acting muscarinic receptor antagonist
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Safety:adverse events, vital sign, ECGs, and clinical laboratory test
Title
PK:Cmax, tmax and AUC(0-t)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests.
Body weight ≥ 50kg and BMI within the range 18.50-25.00kg/m2 inclusive.
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))
Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).
Clinical laboratory tests data obtained at screening meet the following:
AST(GOT), ALT(GPT), total-bilirubin: below the upper limit of the normal ranges
Normal 12-lead EGC finding at screening; QTc interval <450msec
A mean blood pressure lower than 140/90mmHg at screening.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Capable of using the novel dry powder inhaler.
Exclusion Criteria:
The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
A history of breathing problems (i.e. history of asthmatic symptomatology, asthma in childhood).
The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium, atropine and any of its derivatives.
The subject has a known allergy or hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate.
The subject has a history or current conditions of drug abuse or alcoholism.
History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink=5 ounces (150mL) of wine or 350mL of beer or 1.5 ounces (45mL) of 80 proof distilled spirits) within 6 month of screening.
The subject is positive for urine drug screening.
The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" within the previous 1 month.
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
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
12. IPD Sharing Statement
Citations:
Citation
This study has not been published in the scientific literature.
Results Reference
background
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Phase I Study of GSK233705 in Healthy Japanese Male Subjects
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