A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK1278863A in Healthy Subjects
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK1278863A in Healthy Subjects
A first-time in human study to investigate the safety, tolerability, pharmacokinetics and
 pharmacodynamics of GSK1278863A in healthy subjects
Inclusion Criteria:

 -  Healthy, non-smoking (within 40 days of screening), adult males and females between 18
 and 55 years of age, inclusive

 -  Female subjects are eligible for participation in the study if they are of:

 -  Non-childbearing potential (i.e., physiologically incapable of becoming pregnant);

 -  Male subjects agree to use contraception methods

 -  Body weight > or = 50 kg; BMI: 19-31 kg/m2, inclusive

 -  Subject has a QTc <450 msec or <480 msec if associated with bundle branch block

 -  Subject is willing and able to provide written informed consent

 Exclusion Criteria:

 -  MCV value outside the reference range at screening

 -  Hemoglobin value at screening is: male subjects or post-menopausal females > 15.5
 g/dL; female subjects > 14.5 g/dL

 -  TIBC, serum iron and serum ferritin values are outside the reference range at
 screening

 -  Calculated creatinine clearance < 60 ml/min

 -  Clinically significant abnormal CPK determined by the investigator and medical monitor

 -  AST, ALT and direct bilirubin are greater than upper limit of reference range at
 screening

 -  Subjects are unwilling or inability to follow the procedures and lifestyle and/or
 dietary restrictions outlined in the protocol

 -  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, unless in the opinion of the Investigator and
 GSK Medical Monitor this will not interfere with the study procedures or compromise
 subject safety

 -  Subject currently exposures to more than four new chemical entities within 12 months
 prior to the first dosing day

 -  Use of other prescription or non-prescription drugs, vitamins, herbal and dietary
 supplements, within 7 days prior to the first dose of study medication

 -  Subject has a history of sensitivity to any of the study medications, or components
 thereof or a history of drug or other allergy

 -  Subjects with a pre-existing condition interfering with normal gastrointestinal
 anatomy or motility, hepatic and/or renal function, that could interfere with the
 absorption, metabolism, and/or excretion of the study drugs.

 -  Subject has a history of GI ulceration or gastrointestinal bleeding

 -  Subject has a history of peptic ulcer disease

 -  Subject has a history of malignancy tumor; non-melanoma skin cancer that has been
 definitely removed is allowed

 -  Treatment with an investigational drug within 30 days preceding the first dose of
 study medication

 -  Subjects with a history of drug abuse

 -  History of regular alcohol consumption exceeding 7 drinks/week for females or 14
 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of
 hard liquor) within 6 months of screening

 -  Positive urine drug screen (UDS) at screening

 -  Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
 or positive HIV result within 3 months of screening

 -  Donation of blood in excess of 500 mL within 56 days prior to first dose of study
 medication

 -  Subject has a history of regular use of tobacco- or nicotine containing products

 -  History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to
 any of the study medications or components thereof