Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03156439 | Bioavailability, Safety, and Tolerability of BIS-001 ER | PHASE1 | COMPLETED | 8 | — | — | May 22, 2017 | Sep 30, 2017 | Jan 18, 2018 | 1 | Australia |
Bioavailability/Pharmacokinetic Assessments
Bioavailability/Pharmacokinetic Assessments
Bioavailability/Pharmacokinetic Assessments
Bioavailability/Pharmacokinetic Assessments
Bioavailability/Pharmacokinetic Assessments
Bioavailability/Pharmacokinetic Assessments
Bioavailability/Pharmacokinetic Assessments
Bioavailability/Pharmacokinetic Assessments
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| BIS-001 ER | DRUG | BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A. |
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....