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Bioavailability, Safety, and Tolerability of BIS-001 ER

NCT03156439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-01-18

No results posted yet for this study

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.

Conditions

  • Epilepsy, Complex Partial

Interventions

DRUG

BIS-001 ER

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

Sponsors & Collaborators

  • Melbourne Health

    collaborator OTHER

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen D Collins · President and CEO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03156439 on ClinicalTrials.gov