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Bioavailability, Safety, and Tolerability of BIS-001 ER

Primary Purpose

Epilepsy, Complex Partial

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BIS-001 ER
Sponsored by
Supernus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Complex Partial

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIS-001 ER

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum serum concentration; Cmax
Bioavailability/Pharmacokinetic Assessments
Area under the curve; AUC
Bioavailability/Pharmacokinetic Assessments
Time of maximum serum concentration; Tmax
Bioavailability/Pharmacokinetic Assessments
Half-life; t1/2
Bioavailability/Pharmacokinetic Assessments
Terminal elimination
Bioavailability/Pharmacokinetic Assessments
Clearance
Bioavailability/Pharmacokinetic Assessments
Volume of distribution
Bioavailability/Pharmacokinetic Assessments
Mean residence time
Bioavailability/Pharmacokinetic Assessments

Secondary Outcome Measures

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.
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.
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.
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.
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.
Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology
Laboratory assessments will be conducted using standard methods.
Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry
Laboratory assessments will be conducted using standard methods.
Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis
Laboratory assessments will be conducted using standard methods.

Full Information

First Posted
May 15, 2017
Last Updated
January 16, 2018
Sponsor
Supernus Pharmaceuticals, Inc.
Collaborators
Melbourne Health
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1. Study Identification

Unique Protocol Identification Number
NCT03156439
Brief Title
Bioavailability, Safety, and Tolerability of BIS-001 ER
Official Title
Evaluation of the Bioavailability, Safety, and Tolerability of BIS-001 ER Following Multiple Dose Administration in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.
Collaborators
Melbourne Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Complex Partial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIS-001 ER
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BIS-001 ER
Other Intervention Name(s)
Huperzine A
Intervention Description
BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
Primary Outcome Measure Information:
Title
Maximum serum concentration; Cmax
Description
Bioavailability/Pharmacokinetic Assessments
Time Frame
16 Weeks
Title
Area under the curve; AUC
Description
Bioavailability/Pharmacokinetic Assessments
Time Frame
16 Weeks
Title
Time of maximum serum concentration; Tmax
Description
Bioavailability/Pharmacokinetic Assessments
Time Frame
16 Weeks
Title
Half-life; t1/2
Description
Bioavailability/Pharmacokinetic Assessments
Time Frame
16 Weeks
Title
Terminal elimination
Description
Bioavailability/Pharmacokinetic Assessments
Time Frame
16 Weeks
Title
Clearance
Description
Bioavailability/Pharmacokinetic Assessments
Time Frame
16 Weeks
Title
Volume of distribution
Description
Bioavailability/Pharmacokinetic Assessments
Time Frame
16 Weeks
Title
Mean residence time
Description
Bioavailability/Pharmacokinetic Assessments
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Safety and Tolerability Assessments - Adverse Events
Description
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.
Time Frame
16 Weeks
Title
Safety and Tolerability Assessments - Vital Signs
Description
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.
Time Frame
16 Weeks
Title
Safety and Tolerability Assessments - Neurological Evaluation
Description
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.
Time Frame
16 Weeks
Title
Safety and Tolerability Assessments - Physical Evaluation
Description
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.
Time Frame
16 Weeks
Title
Safety and Tolerability Assessments - ECG Evaluation
Description
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.
Time Frame
16 Weeks
Title
Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology
Description
Laboratory assessments will be conducted using standard methods.
Time Frame
16 Weeks
Title
Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry
Description
Laboratory assessments will be conducted using standard methods.
Time Frame
16 Weeks
Title
Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis
Description
Laboratory assessments will be conducted using standard methods.
Time Frame
16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen D Collins
Organizational Affiliation
President and CEO
Official's Role
Study Chair
Facility Information:
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia

12. IPD Sharing Statement

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Bioavailability, Safety, and Tolerability of BIS-001 ER

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