This is a phase 1b study. Written informed consent will be obtained from each study participant before any study-specific procedures or assessments are done.
At various time points noted below, pharmacokinetic (PK) blood sampling will be performed on study participants.
Throughout the study the investigator will be assessing adverse events and concomitant medication.
On-Study/On-Interventions Evaluations/procedures: Participants will arrive at the Phase 1 unit after fasting a minimum of 10 hours, for admission into the unit and will undergo procedures:
* Medical and medication histories
* Infection screen
* Body temperature
* Vital signs (blood pressure and heart rate)
* Physical examination and weight
* Neurological exam
* Safety laboratory tests (blood and urine)
* Urine pregnancy test (females only)
* Alcohol screening (Breathalyzer)
* Urine drug screen
* Hepatitis B, C and HIV screening
* Randomize: Only participants who meet eligibility requirements will be randomized into the study.
Day 1 - Dosing: A light breakfast will be given prior to dosing. Participants will have the following tests/procedures performed at various time points during the day following confirmation of eligibility.
* 8 electrocardiograms (ECG)
* 8 vital signs (blood pressure and heart rate)
* 1 body temperature
* 12 PK Blood draws
* 2 study drug administrations
Day 2: A light breakfast will be given prior to dosing.
* 8 ECGs
* 8 vital signs (blood pressure and heart rate)
* 1 body temperature
* 1 PK blood draw
* 2 study Drug administration
Day 3: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given before dosing
* 1 safety laboratory tests (blood and urine)
* 1 ECG
* 2 vital signs (blood pressure and heart rate)
* 1 body temperature
* 1 PK blood draw
* 1 neurological examination
* 2 study drug administrations
Day 4: A Light breakfast will be given before dosing
* 2 vital signs (blood Pressure and heart rate)
* 1 body temperature
* 1 PK blood draw
* 2 study drug administrations
Day 5: A Light breakfast will be given before dosing
* 1 ECG
* 2 vital signs (Blood Pressure and heart rate)
* 1 body temperature
* 12 PK blood draw
* 2 study drug administration
Day 6: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given
* 1 safety laboratory test (blood and urine)
* 1 vital sign (Blood pressure and heart rate)
* 1 body temperature
* 1 neurological examination
* 2 PK blood draw
Day 7: A light breakfast will be provided
* 1 vital sign
* 1 body temperature
* 1 PK blood draw
Day 8 (Discharge): Participants will fast for a minimum of 10 hours. Water is allowed. A light breakfast will be offered
* 1 safety laboratory test (blood and urine)
* 1 ECG
* 1 vital sign (blood pressure and heart rate)
* 1 body temperature
* 1 physical examination including weight
* 1 neurological examination
2 Week Follow-up Visit: Participants will fast for a minimum of 10 hours. Water is allowed.
during this visit participants will have the following tests and procedures performed:
* 1 safety laboratory test (blood and urine)
* 1 ECG
* 1 vital sign (blood pressure and heart rate)
* 1 body temperature
6-8 Week Follow-up Phone Call: Participants will be asked about any adverse events and any medications they may be taking.
