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
- 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
- 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
- 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
- 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.