Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAMA | Experimental | After randomization subject will inhale either GSK233705 50, 100 or 200 microgram once daily for 7 days. |
|
| Placebo | Placebo Comparator | After randomization subjects will inhale placebo once daily for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK233705 | Drug | Inhaled Long acting muscarinic receptor antagonist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety:adverse events, vital sign, ECGs, and clinical laboratory test | ||
| PK:Cmax, tmax and AUC(0-t) |
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fukuoka | 812-0025 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. |
| Label | URL |
|---|---|
| Results for study 112016 can be found on the GSK Clinical Study Register. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Matching placebo |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |