Bioavailability, Safety, and Tolerability of BIS-001 ER

Epilepsy, Complex Partial Clinical Trial

Official title:

Evaluation of the Bioavailability, Safety, and Tolerability of BIS-001 ER Following Multiple Dose Administration in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156439
• Other study ID #: BNI-01-1b
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2017
• Last updated: January 16, 2018
• Start date: May 22, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: January 2018
• Source: Biscayne Neurotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy, Complex Partial

Intervention

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

Locations

Country	Name	City	State
Australia	The Royal Melbourne Hospital	Parkville	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Biscayne Neurotherapeutics, Inc.	Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum serum concentration; Cmax	Bioavailability/Pharmacokinetic Assessments	16 Weeks
Primary	Area under the curve; AUC	Bioavailability/Pharmacokinetic Assessments	16 Weeks
Primary	Time of maximum serum concentration; Tmax	Bioavailability/Pharmacokinetic Assessments	16 Weeks
Primary	Half-life; t1/2	Bioavailability/Pharmacokinetic Assessments	16 Weeks
Primary	Terminal elimination	Bioavailability/Pharmacokinetic Assessments	16 Weeks
Primary	Clearance	Bioavailability/Pharmacokinetic Assessments	16 Weeks
Primary	Volume of distribution	Bioavailability/Pharmacokinetic Assessments	16 Weeks
Primary	Mean residence time	Bioavailability/Pharmacokinetic Assessments	16 Weeks
Secondary	Safety and Tolerability Assessments - Adverse Events	Adverse events will be defined, documented, evaluated (mild/moderate/severe/life threatening; serious/non-serious; expected/unexpected; causally related to study drug or not) and reported according to all applicable institutional and governmental requirements and guidance.	16 Weeks
Secondary	Safety and Tolerability Assessments - Vital Signs	Vital signs (e.g. blood pressure) will be monitored through the first 8 hrs after drug administration, as well as at Baseline and pre-dose.	16 Weeks
Secondary	Safety and Tolerability Assessments - Neurological Evaluation	A standard neurological examination will be performed according to the study-specific timeline. Clinically significant new or worsened abnormalities as compared to baseline findings will have to be reported as AEs.	16 Weeks
Secondary	Safety and Tolerability Assessments - Physical Evaluation	A standard physical examination will be performed according to the study-specific timeline. Clinically significant new or worsened abnormalities as compared to baseline findings will have to be reported as AEs.	16 Weeks
Secondary	Safety and Tolerability Assessments - ECG Evaluation	A standard 12-lead ECG in a supine position after a 5-minute rest will be performed according to the study-specific timeline.; The Investigator will determine whether the results of the ECG are normal or abnormal and assess the clinical significance of any abnormality. ECG tracings will be reviewed by a cardiologist if required.	16 Weeks
Secondary	Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology	Laboratory assessments will be conducted using standard methods.	16 Weeks
Secondary	Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry	Laboratory assessments will be conducted using standard methods.	16 Weeks
Secondary	Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis	Laboratory assessments will be conducted using standard methods.	16 Weeks