Epilepsy, Complex PartialPhase 1NCT03156439
Bioavailability, Safety, and Tolerability of BIS-001 ER
A Phase 1 study testing BIS-001 ER in people with Epilepsy, Complex Partial, run by Supernus Pharmaceuticals, Inc. at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Complex Partial
- What is being tested?
- BIS-001 ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- 22 May 2017to 30 Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Bioavailability, Safety, and Tolerability of BIS-001 ER Following Multiple Dose Administration in Healthy Subjects
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
- Being tested
- BIS-001 ER
- Medical subject headings
- Epilepsy, Complex Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS-001 ERDrug
Also called Huperzine A
BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BIS-001 ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum serum concentration; Cmax
Bioavailability/Pharmacokinetic Assessments
Measured: 16 Weeks
Area under the curve; AUC
Bioavailability/Pharmacokinetic Assessments
Measured: 16 Weeks
Time of maximum serum concentration; Tmax
Bioavailability/Pharmacokinetic Assessments
Measured: 16 Weeks
Half-life; t1/2
Bioavailability/Pharmacokinetic Assessments
Measured: 16 Weeks
Terminal elimination
Bioavailability/Pharmacokinetic Assessments
Measured: 16 Weeks
Clearance
Bioavailability/Pharmacokinetic Assessments
Measured: 16 Weeks
Volume of distribution
Bioavailability/Pharmacokinetic Assessments
Measured: 16 Weeks
Mean residence time
Bioavailability/Pharmacokinetic Assessments
Measured: 16 Weeks
Secondary outcomes (8)
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.
Measured: 16 Weeks
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.
Measured: 16 Weeks
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.
Measured: 16 Weeks
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.
Measured: 16 Weeks
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.
Measured: 16 Weeks
Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology
Laboratory assessments will be conducted using standard methods.
Measured: 16 Weeks
Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry
Laboratory assessments will be conducted using standard methods.
Measured: 16 Weeks
Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis
Laboratory assessments will be conducted using standard methods.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start22 May 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Complex PartialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Melbourne Health
- Responsible party
- Sponsor
- Investigators
- Stephen D Collins, Study chair, President and CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156439
- Sponsor's protocol ID
- BNI-01-1b
- Status last verified
- Jan 2018
- First submitted
- 15 May 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bioavailability, Safety, and Tolerability of BIS-001 ER Following Multiple Dose Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03156439
- Acronym / sponsor ID
- BNI-01-1b
- Conditions
- Epilepsy, Complex Partial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Melbourne Health
- Study start
- 22 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIS-001 ER | Experimental | Drug: BIS-001 ERThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS-001 ERAlso: Huperzine ABIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A. | Drug | BIS-001 ER |
Primary outcome
Maximum serum concentration; Cmax
Time frame: 16 Weeks
Bioavailability/Pharmacokinetic Assessments
Area under the curve; AUC
Time frame: 16 Weeks
Bioavailability/Pharmacokinetic Assessments
Time of maximum serum concentration; Tmax
Time frame: 16 Weeks
Bioavailability/Pharmacokinetic Assessments
Half-life; t1/2
Time frame: 16 Weeks
Bioavailability/Pharmacokinetic Assessments
Terminal elimination
Time frame: 16 Weeks
Bioavailability/Pharmacokinetic Assessments
Clearance
Time frame: 16 Weeks
Bioavailability/Pharmacokinetic Assessments
Volume of distribution
Time frame: 16 Weeks
Bioavailability/Pharmacokinetic Assessments
Mean residence time
Time frame: 16 Weeks
Bioavailability/Pharmacokinetic Assessments
8 secondary outcomes
Safety and Tolerability Assessments - Adverse Events
Time frame: 16 Weeks
Safety and Tolerability Assessments - Vital Signs
Time frame: 16 Weeks
Safety and Tolerability Assessments - Neurological Evaluation
Time frame: 16 Weeks
Safety and Tolerability Assessments - Physical Evaluation
Time frame: 16 Weeks
Safety and Tolerability Assessments - ECG Evaluation
Time frame: 16 Weeks
Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology
Time frame: 16 Weeks
Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry
Time frame: 16 Weeks
Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis
Time frame: 16 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Collins study chair
President and CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIS-001 ER in people with Epilepsy, Complex Partial, run by Supernus Pharmaceuticals, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum serum concentration; Cmax (time frame: 16 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.