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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03156439




Registration number
NCT03156439
Ethics application status
Date submitted
15/05/2017
Date registered
17/05/2017
Date last updated
18/01/2018

Titles & IDs
Public title
Bioavailability, Safety, and Tolerability of BIS-001 ER
Scientific title
Evaluation of the Bioavailability, Safety, and Tolerability of BIS-001 ER Following Multiple Dose Administration in Healthy Subjects
Secondary ID [1] 0 0
BNI-01-1b
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy, Complex Partial 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIS-001 ER

Experimental: 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.


Treatment: Drugs: BIS-001 ER
BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum serum concentration; Cmax
Timepoint [1] 0 0
16 Weeks
Primary outcome [2] 0 0
Area under the curve; AUC
Timepoint [2] 0 0
16 Weeks
Primary outcome [3] 0 0
Time of maximum serum concentration; Tmax
Timepoint [3] 0 0
16 Weeks
Primary outcome [4] 0 0
Half-life; t1/2
Timepoint [4] 0 0
16 Weeks
Primary outcome [5] 0 0
Terminal elimination
Timepoint [5] 0 0
16 Weeks
Primary outcome [6] 0 0
Clearance
Timepoint [6] 0 0
16 Weeks
Primary outcome [7] 0 0
Volume of distribution
Timepoint [7] 0 0
16 Weeks
Primary outcome [8] 0 0
Mean residence time
Timepoint [8] 0 0
16 Weeks
Secondary outcome [1] 0 0
Safety and Tolerability Assessments - Adverse Events
Timepoint [1] 0 0
16 Weeks
Secondary outcome [2] 0 0
Safety and Tolerability Assessments - Vital Signs
Timepoint [2] 0 0
16 Weeks
Secondary outcome [3] 0 0
Safety and Tolerability Assessments - Neurological Evaluation
Timepoint [3] 0 0
16 Weeks
Secondary outcome [4] 0 0
Safety and Tolerability Assessments - Physical Evaluation
Timepoint [4] 0 0
16 Weeks
Secondary outcome [5] 0 0
Safety and Tolerability Assessments - ECG Evaluation
Timepoint [5] 0 0
16 Weeks
Secondary outcome [6] 0 0
Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology
Timepoint [6] 0 0
16 Weeks
Secondary outcome [7] 0 0
Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry
Timepoint [7] 0 0
16 Weeks
Secondary outcome [8] 0 0
Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis
Timepoint [8] 0 0
16 Weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2017
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Supernus Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03156439
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen D Collins
Address 0 0
President and CEO
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03156439