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This is a randomized, double blind, placebo controlled, parallel-group, 7 day repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose of GW642444M from a novel dry powder device in healthy Japanese male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LABA | Experimental | After randomization subject will inhale either 12.5 microgram or 25 microgram GW642444M 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 |
|---|---|---|---|---|
| GW642444 | Drug | Long acting Beta 2 agonist |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety:adverse events, vital sign, ECGs, and clinical laboratory test | ||
| PK:Cmax, tmax and AUC(0-t) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics parameters of the systemic β-adrenergic effect (heart rate, blood pressure, QTc, glucose and potassium) |
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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 18.5-25.0kg/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
Serum potassium and glucose within normal range at screening
Normal 12-lead EGC finding at screening; QTc interval <450msec
A mean heart rate within the range 40-90 beats per minute (bpm) inclusive at screening.
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:
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| 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 |
|---|---|---|---|
| 23735179 | Background | Nakahara N, Wakamatsu A, Kempsford R, Allen A, Yamada M, Nohda S, Hirama T. The safety, pharmacokinetics and pharmacodynamics of a combination of fluticasone furoate and vilanterol in healthy Japanese subjects. Int J Clin Pharmacol Ther. 2013 Aug;51(8):660-71. doi: 10.5414/CP201822. |
| Label | URL |
|---|---|
| Results for study 112017 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112017 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Drug |
Matching placebo |
|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112017 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112017 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112017 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112017 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |