Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects

NCT05102552 | Completed Early Phase 1

• 1 other identifier: 817P106
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, Open-Label, Multiple Dose study to evaluate the relative bioavailability of Treatment A, Treatment B, and Treatment C

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Relative Bioavailability

  Area under the curve (AUC)

  22 days

• Relative Bioavailability

  Peak (Cmax) plasma concentration

  22 days

Secondary Outcomes (1)

• To assess the safety and tolerability of multiple oral administration of SPN-817 in healthy adult subjects.

  25 days

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

BIS-001: Treatment A and SPN-817: Treatment B

Drug: SPN-817, Treatment B; Drug: BIS-001, Treatment A

Cohort 2

ACTIVE COMPARATOR

BIS-001: Treatment A and SPN-817: Treatment C

Drug: SPN-817, Treatment C; Drug: BIS-001, Treatment A

Interventions

SPN-817, Treatment B DRUG

SPN-817 Treatment B, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor

Also known as: Huperzine A

Cohort 1

SPN-817, Treatment C DRUG

SPN-817 Treatment C, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor

Also known as: Huperzine A

Cohort 2

BIS-001, Treatment A DRUG

BIS-001 is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor

Also known as: Huperzine A

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or female volunteers, 18-55 years of age inclusive.
• Weight of at least 50 kg and within the normal Body Mass Index (BMI) between 18 - 32 kg/m2 (inclusive).
• Considered medically healthy by the Investigator via assessment of physical and neurological examinations, medical history, clinical laboratory tests, vital signs, and electrocardiogram (ECG)
• Able and willing to swallow whole capsules and capsule contents without breaking, cutting, or chewing.
• Able to voluntarily provide written informed consent to participate in the study.
• Post-menopausal females with amenorrhea for at least 12 months with a serum follicle stimulating hormone \[FSH\] level of \>40 IU/L) or women of non-childbearing potential (WONCBP) who are permanently sterilized (bilateral tubal ligation, hysterectomy, bilateral oophorectomy for six months minimum prior to screening).
• Non-pregnant females of childbearing potential who are either sexually inactive (abstinent) or, if sexually active with a male partner who is biologically capable of having children, agree to use one of the following acceptable birth control methods beginning 14 days prior to the first dose, throughout the study, and for 30 days following the last dose:
• Hormonal contraceptive (i.e., oral, transdermal/subdermal; implant or injection)
• Intrauterine device (IUD)
• Double contraceptive methods (e.g. oral contraception and condom)
• Vasectomized partner (6 months minimum)
• Male subjects who are biologically capable of having children (i.e., non-vasectomized) who are sexually inactive (abstinent) or, if sexually active with a female of childbearing potential, must agree to use one or more of the above forms of birth control for themselves and their partner(s), as appropriate, beginning 14 days prior to the first dose through at least 90 days following the last administration of study drug. They must also agree to abstain from sperm donation from the first administration of study drug to 90 days after the last administration of study drug.

You may not qualify if:

• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
• Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts, or more than one lifetime suicide attempt) within six months before Screening, or at Screening and Day -1 as determined by C-SSRS.
• Evidence of infection with Hepatitis B or C, or human immunodeficiency virus HIV-1 or HIV2, as determined by results of testing at screening.
• Positive urine drug screen (for amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, tetrahydrocannabinol and phencyclidine) at Screening and at Day -1.
• Clinically significant cardiology abnormalities at Screening and Day -1.
• Abnormal ECG that is, in the investigator's opinion, clinically significant including heart rate \<50 BPM (average of 3);
• PR interval \> 220 ms;
• QRS interval ≥ 120 ms;
• QTcF interval \> 450 ms (QT corrected using Fridericia's method);
• Second or third-degree atrioventricular block;
• Any rhythm, other than sinus rhythm, that is interpreted by the investigator to be clinically significant.
• Creatinine clearance \< 80 mL/min, according to the Cockcroft-Gault equation at Screening or Day -1.
• Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate \[HR\] less than 50 or over 100 bpm) at Screening or check-in on Day -1.
• History of intellectual disability (intellectual developmental disorder) or mental retardation.
• A history of neuroleptic malignant syndrome.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Interventions

huperzine A

Study Officials

• Jeanelle Portelli, Ph.D.

  Supernus Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: November 1, 2021
• Study Start: October 19, 2021
• Primary Completion: March 25, 2022
• Study Completion: August 15, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)