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This is a single centre, randomized, double blind, placebo controlled, single and repeat dose study to investigate the safety, tolerability, and pharmacokinetics of inhaled dose of GSK573719 with lactose and containing magnesium stearate by a novel dry powder device in healthy Japanese male subjects.
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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
Normal 12-lead EGC finding at screening; QTc(B) 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
Primary purpose
Allocation
Interventional model
Masking
48 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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