to assess the excretion balance and pharmacokinetics of a single oral dose of [14c]gw856553 in healthy adult males

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this will be an open label study conducted at one site. six healthy male subjects will be enrolled to ensure at least four fully evaluable subjects. each subject will receive a single 10 milligram (mg) oral dose of gw856553 containing 50 microci (µci) of \[14c\] gw856553. urine and fecal samples will be collected until 216 hour after dosing but subjects may be discharged after 168 hour if 90% of the dose is recovered and/or \<1% of the dose is excreted in a 24 hour period. blood and plasma will be collected at various sample times after dosing to measure parent drug and total drug-related material. samples of urine, faeces and plasma will be transferred into a separate study to characterize and quantify metabolites in these matrices. safety will be assessed by adverse event monitoring, vital signs, electrocardiogram (ecg) and clinical laboratory tests.


Eligibility criteria:
inclusion criteria: * healthy male aged between 30 and 60 years inclusive, at the time of screening. * body weight \>/ 50 kilogram (kg). * a body mass index (bmi) within the range of 18.5 to 29.9 kg/ meter square (m\^2) inclusive. * signed and dated written informed consent prior to admission to the study. * the subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. exclusion criteria: * any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ecg (12-lead). * significant cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions that in the opinion of the investigator and/or gsk medical monitor, places the subject at an unacceptable risk as participant in this trial. * qt interval corrected by bazett's formula (qtcb) \> 450 milliseconds (msecs) * a definite or suspected personal or family history of adverse reactions or hypersensitivity to the trial drug or to drugs with a similar chemical structure. * history of regular alcohol consumption exceeding an average weekly intake of \> 21 units (or an average daily intake of greater than 3 units). one unit is equivalent to a half-pint \[284 milliliter (ml)\] of beer/lager; 25ml measure of spirits or 125ml of wine). * subjects with a history or presence of gastro-intestinal or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. * subjects who have consumed grapefruit or grapefruit juice within seven days of the first study day. * subjects who have had exposure to more than three new chemical entities within 12 months prior to the first dosing period. * subjects who have participated in a trial with a different new chemical entity within 90 days prior to the start of this study. * if participation in the study will result in the volunteer having donated more than 400ml of blood in the previous 56 days. * subjects who have received a total body radiation dose of greater than 5.0 msv (upper limit of who category ii) or exposure to significant radiation (e.g. serial x-ray or ct scans, barium meal etc) in the 12 months prior to this study. * history of elevated blood pressure or blood pressure persistently \>140/90 mmhg at screening. * an unwillingness to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an iud, diaphragm with spermicide, oral contraceptives, injectable progesterone, sub dermal implants or a tubal ligation if the women could become pregnant from the time of the first dose of the study medication until completion of the follow-up procedures. * lack of suitability for participation in this study, for any reason, in the opinion of the investigator. * any condition that could interfere with the accurate assessment and recovery of 14c. * prescribed or over-the-counter medication within 5 days (or 5 half lives, whichever is longer) prior to the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome. * liver function tests (alt, ast, alp, gamma gt and bilirubin) \> upper limit of normal (uln) at screening * positive urine drug screen * positive hiv, hepatitis b or c result at screening. * history of use of tobacco- or nicotine-containing products within 6 months of screening or a positive urine cotinine screen (urine cotinine \> 250ng/ml).

Keywords: gw856553, radiolabel adme,