Bioavailability, Safety, and Tolerability of BIS-001 ER

Supernus Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Epilepsy, Complex Partial

Treatments: Drug: BIS-001 ER

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03156439

BNI-01-1b

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

BIS-001 ER

Experimental group

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.

Treatment:

Drug: BIS-001 ER