To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]GW856553 in Healthy Adult Males

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring GW856553,, radiolabel, ADME, Read More

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).