a healthy volunteer study with inhaled gsk573719 and placebo

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study is to look at a new formulation of gsk573719 to see if it is safe and tolerated in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy. * male or female 18 to 65 years of age inclusive. * non-childbearing women or women of child bearing potential who agree to use contraception * subject has had their cyp2d6 genotype confirmed and can be included in either of the following parts: * part 1: may include extensive, intermediate and ultra-rapid metabolizers * part 2: includes only poor (no enzyme activity) metabolizers, with previously confirmed phenotype * body mass index within the range 18 - 30 kg/m2 (inclusive). * capable of giving written informed consent * normal ecg; * normal lung function. * 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)) * 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 exclusion criteria: * any clinically important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ecg (12-lead). 24hr holter monitoring outside normal limits. * a history of breathing problems (i.e. history of asthmatic symptomatology). * abnormal ecg. * abnormal blood pressure. * abnormal heart rate * the subject has a positive pre-study drug/alcohol screen. * a positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within three months of screening. * a positive test for hiv antibody (if determined by the local sops). * history of high alcohol consumption within three months of the study * the subject has participated in a clinical trial and has received an ip within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the ip (whichever is longer). * exposure to more than four new chemical entities within 12 months prior to the first dosing day. * use of prescription or non-prescription drugs, (except for simple analgesics e.g. paracetamol), including vitamins, herbal and dietary supplements (including st john's wort) within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to the first dose of study medication * history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or gsk medical monitor, contraindicates their participation. * where participation in the study would result in donation of blood or blood products in excess of 500ml within a 56 day period. * unwillingness or inability to follow the procedures outlined in the protocol. * urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products prior to screening. * the subject is unable to use the novel dry powder inhaler correctly. * the subject has a known allergy or hypersensitivity to milk protein or the excipients magnesium stearate and lactose monohydrate.

Keywords: healthy volunteers new formulation