Epilepsy, Complex Partial
Conditions
Brief summary
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.
Interventions
DRUGBIS-001 ER
BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
Sponsors
Melbourne Health
Supernus Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Speak English with sufficient proficiency to read and comprehend the Informed Consent document, and to communicate with study staff. 2. Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study. 3. Have signed the Informed Consent before any study-specific procedures are performed 4. Be males or females between 18 - 45 years of age. 5. Have a negative urinary pregnancy test upon admission to the site on Day 1 6. Be in good general health in the judgment of the Principal Investigator based upon medical history, physical examination, standard 12-lead electrocardiogram (ECG), and clinical laboratory evaluations obtained within the two weeks prior to enrollment. 7. Be able to comply with all study-specified procedures. 8. Weight between 40 and 100 kg
Exclusion criteria
1. Has taken Huperzine A. 2. Is planning to become pregnant or impregnate spouse, not using an acceptable method of birth control (defined as use of double-barrier birth control methods, use of oral contraceptives, or surgical sterilization), pregnant or nursing 3. Has a pre-existing medical condition (including an existing progressive or degenerative neurological disorder) or takes medications that, in the Principal Investigator's opinion, could interfere with the subject's suitability for participation in the study. 4. Has a history or evidence of significant psychiatric disturbance or illness, including alcohol or drug abuse within the past 2 years, or symptoms of psychosis (hallucinations, delusions) in the last 5 years. 5. Has had any clinical laboratory abnormalities within the past two months, prior to screening, considered of clinical significance by the Principal Investigator 6. Is on concomitant therapy with non-anti-epileptic drugs (AEDs) that are cholinergic. 7. Has participated in any clinical investigational drug or device study within four weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean residence time | 16 Weeks | Bioavailability/Pharmacokinetic Assessments |
| Maximum serum concentration; Cmax | 16 Weeks | Bioavailability/Pharmacokinetic Assessments |
| Area under the curve; AUC | 16 Weeks | Bioavailability/Pharmacokinetic Assessments |
| Time of maximum serum concentration; Tmax | 16 Weeks | Bioavailability/Pharmacokinetic Assessments |
| Half-life; t1/2 | 16 Weeks | Bioavailability/Pharmacokinetic Assessments |
| Terminal elimination | 16 Weeks | Bioavailability/Pharmacokinetic Assessments |
| Clearance | 16 Weeks | Bioavailability/Pharmacokinetic Assessments |
| Volume of distribution | 16 Weeks | Bioavailability/Pharmacokinetic Assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Assessments - Adverse Events | 16 Weeks | 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. |
| Safety and Tolerability Assessments - Vital Signs | 16 Weeks | 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. |
| Safety and Tolerability Assessments - Neurological Evaluation | 16 Weeks | 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. |
| Safety and Tolerability Assessments - Physical Evaluation | 16 Weeks | 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. |
| Safety and Tolerability Assessments - ECG Evaluation | 16 Weeks | 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. |
| Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology | 16 Weeks | Laboratory assessments will be conducted using standard methods. |
| Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry | 16 Weeks | Laboratory assessments will be conducted using standard methods. |
| Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis | 16 Weeks | Laboratory assessments will be conducted using standard methods. |
Countries
Australia
Outcome results
None listed