Bioavailability, Safety, and Tolerability of BIS-001 ER

NCT03156439 | Completed Phase 1

• 1 other identifier: BNI-01-1b
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Complex Partial

Outcome Measures

Primary Outcomes (8)

• 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

Secondary Outcomes (8)

• Safety and Tolerability Assessments - Adverse Events

  16 Weeks

• Safety and Tolerability Assessments - Vital Signs

  16 Weeks

• Safety and Tolerability Assessments - Neurological Evaluation

  16 Weeks

• Safety and Tolerability Assessments - Physical Evaluation

  16 Weeks

• Safety and Tolerability Assessments - ECG Evaluation

  16 Weeks

Study Arms (1)

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.

Drug: BIS-001 ER

Interventions

BIS-001 ER DRUG

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

Also known as: Huperzine A

BIS-001 ER

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Speak English with sufficient proficiency to read and comprehend the Informed Consent document, and to communicate with study staff.
• Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study.
• Have signed the Informed Consent before any study-specific procedures are performed
• Be males or females between 18 - 45 years of age.
• Have a negative urinary pregnancy test upon admission to the site on Day 1
• 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.
• Be able to comply with all study-specified procedures.
• Weight between 40 and 100 kg

You may not qualify if:

• Has taken Huperzine A.
• 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
• 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.
• 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.
• Has had any clinical laboratory abnormalities within the past two months, prior to screening, considered of clinical significance by the Principal Investigator
• Is on concomitant therapy with non-anti-epileptic drugs (AEDs) that are cholinergic.
• Has participated in any clinical investigational drug or device study within four weeks prior to study entry.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead
• Melbourne Health: collaborator

Study Sites (1)

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Epilepsy, Complex Partial

Interventions

huperzine A

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stephen D Collins

  President and CEO

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: May 22, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

AU (1)