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BIS-001

Phase 1

Epilepsy, Complex Partial | Small molecule | Neurology |Supernus Pharmaceuticals, Inc.|Last Updated: Jan 18, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

BIS-001 · 1 trial · 1 indication

Phase 1 1
NCT03156439Bioavailability, Safety, and Tolerability of BIS-001 EREpilepsy, Complex Partial
COMPLETED8 Analytics
PHASE1COMPLETED
Bioavailability, Safety, and Tolerability of BIS-001 ER
Epilepsy, Complex Partial
NCT031564398
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Study Endpoints

Primary Endpoints

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

Mean residence time
16 Weeks

Bioavailability/Pharmacokinetic Assessments

Secondary Endpoints

Safety and Tolerability Assessments - Adverse Events
16 Weeks
Safety and Tolerability Assessments - Vital Signs
16 Weeks
Safety and Tolerability Assessments - Neurological Evaluation
16 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BIS-001 EREXPERIMENTALThe 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.

Interventions

NameTypeDescription
BIS-001 ERDRUGBIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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....

Countries:Australia
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Frequently asked questions about BIS-001

What is BIS-001 used for?

BIS-001 is an investigational small molecule being developed for the treatment of epilepsy, specifically complex partial seizures. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and bioavailability in clinical trials.

Who makes BIS-001?

BIS-001 is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN. The company is conducting clinical research to evaluate the drug's safety and tolerability in patients with complex partial epilepsy.

What phase is BIS-001 in?

BIS-001 is in Phase 1 clinical development. A Phase 1 study has been completed to evaluate its bioavailability, safety, and tolerability. The drug remains investigational and is not yet approved for commercial use. Further clinical trials would be needed to establish its efficacy and safety profile.

What clinical trials is BIS-001 in?

BIS-001 has one completed clinical trial registered as NCT03156439, titled "Bioavailability, Safety, and Tolerability of BIS-001 ER." This Phase 1 study enrolled 8 participants in Australia, including healthy volunteers aged 18 years and older, and was not randomized or double-blinded.

Is BIS-001 the same as BIS-001 ER?

BIS-001 ER is an extended-release formulation of BIS-001. The completed clinical trial NCT03156439 evaluated the bioavailability, safety, and tolerability of BIS-001 ER in healthy volunteers. Both names refer to the same investigational drug compound being developed by Supernus Pharmaceuticals.