a study investigating blood concentrations of rosuvastatin when co-administered with gw856553 in healthy men

Conditions: Atherosclerosis; Cardiovascular Disease

Summary: this study is being conducted to provide initial safety and tolerability data as well as to provide pk data on potential interactions when gw856553 and rosuvastatin are co-administered in healthy male adults


Eligibility criteria:
inclusion criteria: * healthy adult males, 18-55 years of age, inclusive * 50kg \>body weight \<120kg * body mass index (bmi): 19-30 * must be within 20% of the ideal weight based on height and body frame exclusion criteria: * any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, 12-lead ecg recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern. * subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. inflammatory bowel disease). * positive hiv antibody, hepatitis b surface antigen, hepatitis c antibody, or other chronic hepatic disorders at screening. * subjects with chronic infections such as gingivitis, periodontitis, prostatitis, gastritis, urinary track infections, or any active diseases, including tuberculosis or a history of active tuberculosis. * subjects with any acute infection, symptoms suggestive of sinusitis or significant trauma (burns, fractures). * history of alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of 80 proof distilled spirits) within 6 months of screening. * positive urine drug (including cotinine) and/or alcohol at screening. * a history of smoking within the 3 months prior to screening. * use of prescription or non-prescription drugs, including (but not limited to) vitamins, herbal and dietary supplements (including st. john's wort) within 7 days (or 14 days if the drug is a potential drug inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication. an exception is acetaminophen which is allowed at doses of ≤ 2g/day. * participation in a clinical study where the subject has received a drug or new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication. * the subject has been exposed to more than four new chemical entities within 12 months prior to the first day of dosing. * consumption of any fruit juices (including grapefruit juice) within 7 days prior to the first dose of study medication. * a history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology. * history of increased liver function tests (alt, ast) above upper limit of normal in the past 6 months and/or liver function tests (bilirubin, alt, ast) above upper limit of normal at screening. * a known history of gilbert's syndrome. * history of myopathy or rhabdomyolysis. * qtc interval \> 450msec. * an unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception, such as: an intrauterine devise (iud), diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if the woman could become pregnant from the first dose of study medication until completion of follow-up procedures. * donation of blood in excess of 500 ml within 56 days prior to dosing. * history of sensitivity to heparin or heparin-induced thrombocytopenia. * hypersensitivity to rosuvastatin or any component of the rosuvastatin formulation utilised in this study.

Keywords: gw856553, drug-drug interactions, rosuvastatin