Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Must give written informed consent.
Healthy subjects as determined by no clinically significant deviation from normal as judged by the investigator in medical history, physical examination, ECGs and clinical laboratory evaluations
Body Mass Index of 18-30kg/m^2 inclusive
Males or females ages 18-60, inclusive. Women who are not of childbearing potential may enroll. Women must have a negative pregnancy test within 72 hours prior to start of study drug administration or be surgically sterile.

Exclusion Criteria:

Women who are of childbearing potential
Women who are pregnant or breastfeeding
Women with a positive pregnancy test on enrollment or prior to study drug administration
Male subjects who are unwilling to agree to practice barrier contraception during the study and for three months following dosing
Any significant acute or chronic mental illness
Current or recent gastrointestinal disease that may impact the absorption of the drug
Any major surgery within 4 weeks of enrollment
Donation of blood or plasma to a blood bank or in a clinical study (except screening visit) within 4 weeks of enrollment
Blood transfusion within 4 weeks of enrollment
Inability to tolerate oral medication
Inability to be venipunctured and/or tolerate venous access
Recent (within 6 months) drug or alcohol abuse
History of bleeding disorder
History of head trauma or seizures
Any other sound medical, psychiatric and/or social reason as determined by the Investigator
Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, ECG, or clinical laboratory determinations
Positive urine screen for drugs of abuse
Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, HIV 1/2 antibody
History of any significant drug allergy
Exposure to any investigational drug within 4 weeks prior to enrollment or greater that 4 weeks for investigational drugs that may have a longer half-life
Use of any prescription drugs or over the counter acid controllers within 4 weeks prior to enrollment
Use of any other drugs, including over the counter vitamins, medications and/or herbal preparations within 2 weeks prior to enrollment
Use of oral, injectable or implantable hormonal contraceptive agents within 3 months prior to enrollment
Use of alcohol containing beverages within 1 week prior to enrollment
Use of grapefruit containing products within 1 week prior to enrollment
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious disease) illness must not be enrolled into this study.