Clinical trial NCT03156439: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy, Complex Partial
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Melbourne Health
First posted: 2017-05-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum serum concentration; Cmax
timeFrame: 16 Weeks
measure: Area under the curve; AUC
timeFrame: 16 Weeks
measure: Time of maximum serum concentration; Tmax
timeFrame: 16 Weeks
measure: Half-life; t1/2
timeFrame: 16 Weeks
measure: Terminal elimination
timeFrame: 16 Weeks
measure: Clearance
timeFrame: 16 Weeks
measure: Volume of distribution
timeFrame: 16 Weeks
measure: Mean residence time
timeFrame: 16 Weeks
Secondary outcomes:
measure: Safety and Tolerability Assessments - Adverse Events
timeFrame: 16 Weeks
measure: Safety and Tolerability Assessments - Vital Signs
timeFrame: 16 Weeks
measure: Safety and Tolerability Assessments - Neurological Evaluation
timeFrame: 16 Weeks
measure: Safety and Tolerability Assessments - Physical Evaluation
timeFrame: 16 Weeks
measure: Safety and Tolerability Assessments - ECG Evaluation
timeFrame: 16 Weeks
measure: Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology
timeFrame: 16 Weeks
measure: Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry
timeFrame: 16 Weeks
measure: Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: President and CEO
name: Stephen D Collins
role: STUDY_CHAIR
References: