This study investigates the safety, tolerability, and pharmacokinetics of BIS-001 ER in healthy volunteers. Subjects will be dosed twice daily, with a dose escalation occurring every 2-3 days until a maximum dose of 5mg per day is reached.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Maximum serum concentration; Cmax
Bioavailability/Pharmacokinetic Assessments
Time frame: 16 Weeks
Area under the curve; AUC
Bioavailability/Pharmacokinetic Assessments
Time frame: 16 Weeks
Time of maximum serum concentration; Tmax
Bioavailability/Pharmacokinetic Assessments
Time frame: 16 Weeks
Half-life; t1/2
Bioavailability/Pharmacokinetic Assessments
Time frame: 16 Weeks
Terminal elimination
Bioavailability/Pharmacokinetic Assessments
Time frame: 16 Weeks
Clearance
Bioavailability/Pharmacokinetic Assessments
Time frame: 16 Weeks
Volume of distribution
Bioavailability/Pharmacokinetic Assessments
Time frame: 16 Weeks
Mean residence time
Bioavailability/Pharmacokinetic Assessments
Time frame: 16 Weeks
Safety and Tolerability Assessments - Adverse Events
Adverse events will be defined, documented, evaluated (mild/moderate/severe/life threatening; serious/non-serious; expected/unexpected; causally related to study drug or not) and reported according to all applicable institutional and governmental requirements and guidance.
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Time frame: 16 Weeks
Safety and Tolerability Assessments - Vital Signs
Vital signs (e.g. blood pressure) will be monitored through the first 8 hrs after drug administration, as well as at Baseline and pre-dose.
Time frame: 16 Weeks
Safety and Tolerability Assessments - Neurological Evaluation
A standard neurological examination will be performed according to the study-specific timeline. Clinically significant new or worsened abnormalities as compared to baseline findings will have to be reported as AEs.
Time frame: 16 Weeks
Safety and Tolerability Assessments - Physical Evaluation
A standard physical examination will be performed according to the study-specific timeline. Clinically significant new or worsened abnormalities as compared to baseline findings will have to be reported as AEs.
Time frame: 16 Weeks
Safety and Tolerability Assessments - ECG Evaluation
A standard 12-lead ECG in a supine position after a 5-minute rest will be performed according to the study-specific timeline. The Investigator will determine whether the results of the ECG are normal or abnormal and assess the clinical significance of any abnormality. ECG tracings will be reviewed by a cardiologist if required.
Time frame: 16 Weeks
Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology
Laboratory assessments will be conducted using standard methods.
Time frame: 16 Weeks
Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry
Laboratory assessments will be conducted using standard methods.
Time frame: 16 Weeks
Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis
Laboratory assessments will be conducted using standard methods.
Time frame: 16 Weeks