GSK2190915 Safety and Pharmacokinetic Study in Healthy Japanese Subjects

Exclusion Criteria

• •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• •Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• •Significant cardiac, pulmonary, metabolic, renal, gastrointestinal abnormalities or other conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial.
• •A positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. The detection of drugs with a legitimate medical use would not necessarily be an exclusion to study participation. The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study.
• •A positive test for HIV antibody.
• •History of regular alcohol consumption within 6 months of the study defined as average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
• •The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (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, including CYP3A4 inhibitors and inducers, vitamins, herbal and dietary supplements (including St John's Wort) from 14 days before screening until the follow-up visit, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Hormone Replacement Therapy (HRT) is permitted for post-menopausal females.
• •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.
• •Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
• •Lactating females.
• •Unwillingness or inability to follow the procedures outlined in the protocol.
• •Subject is mentally or legally incapacitated.
• •Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
• •Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.