| Exclusion Criteria: | 1) Sex and Reproductive Status: a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least 3 months (12 weeks) after the last dose of study medication. b) WOCBP using a prohibited contraceptive method (Not applicable for this study). c) Women who are pregnant or breastfeeding.
2) **continued from above: d) Women with a positive pregnancy test on enrollment or prior to investigational product administration. e) Sexually active fertile men whose sexual partner(s) are WOCBP, who are unwilling or unable to use an effective method to avoid pregnancy for the entire study period and for at least 3 months (12 weeks) after completion of study medication.
3) Medical History and Concurrent Diseases: a) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy; b) Dementia or altered mental status.
4) Prohibited Treatments and/or Therapies: a) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including, but not limited to: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chloropromazine, haloperidol, mesoridazine, thioridazine, pimozide, zyprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
5) **continued from above: b) Subjects taking medications known to be potent CYP3A4 inhibitors (i.e.ketoconazole, ritonavir) or inducers (i.e., rifampin, efavirenz).
6) Other Exclusion Criteria: a) Prisoners or subjects who are involuntarily incarcerated; b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. |