A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers

A single-centre, randomised, double-blind, placebo-controlled, dose-ascending, 3-cohort parallel-group study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GSK573719 administered as single doses (750µg and 1000µg) and repeat doses over 14 days (250µg-1000µg once-daily) of GSK573719 in healthy male and female subjects

Inclusion criteria

• Healthy Caucasian male subjects or healthy Caucasian female subjects of non-childbearing potential
• Aged between 18-55 years
• Non-smokers
• Normal spirometry (FEV1 = 80% of predicted, FEV1/FVC = 70%)
• 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
• Subject has a BMI within the range 18.0-30.0kg/m2 inclusive

Exclusion criteria

• Any clinically important abnormality identified at the screening medical assessment
• A history of breathing problems
• A mean QTc(B) value at screening >450msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, or an ECG that is not suitable for QT measurements
• A history of elevated resting blood pressure or a mean blood pressure equal to or higher than 140/90 mmHg at screening
• A mean heart rate outside the range 40-90 bpm at screening
• History of use of tobacco products within 6 months of screening, or positive urine cotinine at screening
• Subjects with a 2D6 poor metabolizer genotype (Caucasian)
• The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study
• The subject is currently taking regular (or course of) medication, whether prescribed or not
• The subject has taken prescription medications within the past 2 weeks prior to dosing or OTC medications within 48 hours prior to dosing
• The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior to dosing
• The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
• The subject has a positive pre-study drug screen
• The subject has a positive pre-study alcohol screen
• The subject has a suspected history of alcohol abuse within the six months previous to the screening visit
• The subject is unable to use the DISKUS
• The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives
• The subject has a known allergy or hypersensitivity to milk protein or the excipient lactose monohydrate
• Subjects who might have prostatic hypertrophy, bladder outlet obstruction, or narrow angle glaucoma