Repeat Dose Safety Study for Compound to Treat Anemia

Exclusion Criteria

• •1. The subject has a positive pre-study drug screen.
• •2. A hemoglobin value at screening is:
• •* Male subjects or post-menopausal females: \> 15.5 g/dL
• •* Female subjects: \> 14.5 g/dL
• •3. The values of hematological parameters at screening are:
• •MCV: outside the reference range and clinically significant deemed by the investigator and GSK Medical Monitor
• •4. The values of the following tests at screening are:
• •* TIBC: outside the reference range
• •* Serum iron: outside the reference range
• •* Serum ferritin: outside the reference range
• •5. A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, direct bilirubin.
• •6. Clinically significant abnormal CPK determined by the investigator and GSK Medical Monitor.
• •7. Calculated creatinine clearance: \< 60mL/min
• •8. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• •9. A positive test for HIV antibody.
• •10. History of drug abuse or dependence within 6 months of the study.
• •11. History of regular alcohol consumption within 6 months of the study
• •12. Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
• •13. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study drug
• •14. History of sensitivity to any of the study drugs, 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.
• •15. History of sensitivity to heparin or heparin-induced thrombocytopenia. (if the clinical research unit uses heparin to maintain intravenous cannula patency)
• •16. Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, and/or hepatic function that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
• •17. History of peptic ulcer disease.
• •18. History of malignancy tumor. Non-melanoma skin cancer that has been definitely removed is allowed.
• •19. Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
• •20. Lactating females.
• •21. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• •22. Unwillingness or inability to follow the procedures, or lifestyle and/or dietary restrictions outlined in the protocol.
• •23. Consumption of red wine, seville oranges, grapefruit or grapefruit juice, exotic citrus fruits, grapefruit hybrids or fruit juices of the prohibited fruits from 7 days prior to the first dose of study medication
• •24. 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).
• •25. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• •26. Subject is mentally or legally incapacitated.