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| Name | Class |
|---|---|
| Melbourne Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIS-001 ER | Experimental | The subjects will be dosed twice daily (BID); in an on-site setting at dose initiation and at times of dose escalation to evaluate safety, and for specimen collection for routine laboratory and pharmacokinetic analysis. Subjects will be discharged and compliance of BID dosing will be monitored via twice daily phone calls by site staff. The initial dose will be 0.5mg BID with a dose escalation every 2-3 days until a maximum tolerated dose is observed or a maximum of 2.5mg BID dose is obtained. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIS-001 ER | Drug | BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration; Cmax | Bioavailability/Pharmacokinetic Assessments | 16 Weeks |
| Area under the curve; AUC | Bioavailability/Pharmacokinetic Assessments | 16 Weeks |
| Time of maximum serum concentration; Tmax | Bioavailability/Pharmacokinetic Assessments | 16 Weeks |
| Half-life; t1/2 | Bioavailability/Pharmacokinetic Assessments | 16 Weeks |
| Terminal elimination | Bioavailability/Pharmacokinetic Assessments | 16 Weeks |
| Clearance | Bioavailability/Pharmacokinetic Assessments | 16 Weeks |
| Volume of distribution | Bioavailability/Pharmacokinetic Assessments | 16 Weeks |
| Mean residence time | Bioavailability/Pharmacokinetic Assessments | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D Collins | President and CEO | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
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| ID | Term |
|---|---|
| D017029 | Epilepsy, Complex Partial |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C050426 | huperzine A |
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| 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. |
| 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. | 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. | 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. | 16 Weeks |
| Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology | Laboratory assessments will be conducted using standard methods. | 16 Weeks |
| Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry | Laboratory assessments will be conducted using standard methods. | 16 Weeks |
| Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis | Laboratory assessments will be conducted using standard methods. | 16 Weeks |
| D009422 |
| Nervous System Diseases |