Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Be a healthy male or female
Be between the ages of 18 and 45 years old, inclusive
Be able and willing to give informed consent
Be able to comply with all study procedures
If female, not be pregnant, including negative serum pregnancy test
If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception during screening and throughout the study: hormonal (i.e., oral, transdermal, implant or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence. Male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate throughout the course of the study
Must not be receiving prescription medication within the 2 weeks before administration of the test dose, except for multivitamins or contraception
Have white blood cell count, hemoglobin, hematocrit and platelet count within normal range for the testing facility
Must have serum chemistry values and urinalysis values within the limits of normal for the testing facility
Must have coagulation parameters within the limits of normal for the testing facility
Must have a negative urine test for substances of abuse including marijuana, cocaine, cocaine derivatives, opiates and methadone

Exclusion Criteria:

Have clinically significant vital signs
Have any clinically significant laboratory value (CBC, serum chemistry, or urinalysis)
Have made a blood donation of 500mL within the 2 months before administration of study medication
Have received a blood transfusion within the 3 months before administration of study medication
Have an acute febrile illness or upper respiratory tract illness within 72 hours prior to administration of study medication
Have received another investigational agent within the 4 weeks before administration of test drug
Have received any other investigational agent during this study
Have any acute or chronic disease (e.g., history of hepatitis or HIV-1)
Have cardiac disease including congestive heart failure or arrhythmia
Have a history of central nervous system disease, such as seizures
Be breast feeding a child
Have been a smoker in the past 12 months
Have Body Mass Index (BMI) > 33 kg/m2