Bioavailability, Safety, and Tolerability of BIS-001 ER

NCT ID: NCT03156439

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2017-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIS-001 ER

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.

Group Type: EXPERIMENTAL

BIS-001 ER

Intervention Type: DRUG

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

Interventions

BIS-001 ER

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

Intervention Type: DRUG

Other Intervention Names

Huperzine A

Eligibility Criteria

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.

3. Have signed the Informed Consent before any study-specific procedures are performed

4. Be males or females between 18 - 45 years of age.

5. Have a negative urinary pregnancy test upon admission to the site on Day 1

6. 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.

7. Be able to comply with all study-specified procedures.

8. Weight between 40 and 100 kg

Exclusion Criteria

1. Has taken Huperzine A.

2. 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

3. 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.

4. 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.

5. Has had any clinical laboratory abnormalities within the past two months, prior to screening, considered of clinical significance by the Principal Investigator

6. Is on concomitant therapy with non-anti-epileptic drugs (AEDs) that are cholinergic.

7. Has participated in any clinical investigational drug or device study within four weeks prior to study entry.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Melbourne Health

OTHER

Sponsor Role: collaborator

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen D Collins

Role: STUDY_CHAIR

President and CEO

Locations

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Countries

Australia

Other Identifiers

BNI-01-1b

Identifier Type: -

Identifier Source: org_study_id