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Healthy VolunteerEarly Phase 1NCT05102552

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

A Early Phase 1 study testing SPN-817, Treatment B, SPN-817, Treatment C and BIS-001, Treatment A in people with Healthy Volunteer, run by Supernus Pharmaceuticals, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
SPN-817, Treatment B, SPN-817, Treatment C and BIS-001, Treatment A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteAustralia
Study dates
19 Oct 2021to 15 Aug 2022
Phase
Early 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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);
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  • 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.
  • A history of cancer within 5 years prior to screening or between screening and randomization (with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin), any history of renal cell carcinoma or breast cancer, or a family history of lymphangioleiomyomatosis in association with tuberous sclerosis complex (TSC-LAM).
  • A history of clinically significant head trauma, including closed head injury with loss of consciousness.
  • A history of seizure, loss of consciousness for an unknown reason, or any other known neurological disorder placing the subject at risk for seizures.
  • History of significant alcohol abuse or drug abuse within one year prior to screening.
  • Regular use of alcohol within six months prior to Screening (more than 14 units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) or positive alcohol breath test at Screening or Day -1.
  • Use of drugs of abuse (such as cocaine, phencyclidine, amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, tetrahydrocannabinol and phencyclidine ) within one year prior to Screening, or positive urine drug screen (for amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, tetrahydrocannabinol and phencyclidine) at Screening or Day -1.
  • History of an allergic reaction to investigational product or related drugs, such as those with similar mechanism of action.
  • History of previous exposure to investigational product in a clinical trial.
  • Female subjects who are pregnant or lactating.
  • Use of prescription medication within 14 days prior to administration of study drug, or over-the-counter products (including natural food supplements) within seven days prior to administration of study drug. Exceptions include topical products without systemic absorption, hormonal contraceptives, hormone replacement therapy (stable dose for at least 30 days), and acetaminophen (2 g/day).
  • Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
  • History of anaphylaxis or severe allergy to any drug, food, toxin, or other exposure.
  • Subjects who received any investigational drug, device or biologic within 3 months or 5 half-lives (whichever is longer) of Day 1 dosing of study drug.
  • Subjects who have had the following blood or plasma donation:
  • Subjects who donated 50 to 499mL of blood within 30 days and more than 499mL within 56 days prior to the first dose or have hemoglobin <128 g/L (males) or <115 g/L (females) and hematocrit <0.37 L/L (males) or <0.32 L/L (females) at Screening.
  • Subjects who have had donated plasma within 7 days prior to dosing
  • Tobacco use as indicated by > 5 cigarettes per week or the equivalent, 30 days prior to Day -1.
  • Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Single-Center, Randomized, Open-label, Multiple-Dose, Single-Sequence Crossover Study, Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects

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

Read the detailed description

A Single-Center, Randomized, Open-label, Multiple-Dose, Single-Sequence Crossover Study, Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects

Being tested
SPN-817, Treatment B, SPN-817, Treatment C, BIS-001, Treatment A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPN-817, Treatment BDrug

    Also called Huperzine A

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

  • SPN-817, Treatment CDrug

    Also called Huperzine A

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

  • BIS-001, Treatment ADrug

    Also called Huperzine A

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

Study groups in NCT05102552
Study groupRoleWhat they receive
Cohort 1Active comparatorBIS-001: Treatment A and SPN-817: Treatment B
Receives: Drug: SPN-817, Treatment B; Drug: BIS-001, Treatment A
Cohort 2Active comparatorBIS-001: Treatment A and SPN-817: Treatment C
Receives: Drug: SPN-817, Treatment C; Drug: BIS-001, Treatment A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative Bioavailability

    Area under the curve (AUC)

    Measured: 22 days

  2. Relative Bioavailability

    Peak (Cmax) plasma concentration

    Measured: 22 days

Secondary outcomes (1)

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

    Adverse Events (occurrence/incidence, seriousness, severity, and causality assessment)

    Measured: 25 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start19 Oct 2021
  3. Primary completion25 Mar 2022
  4. Study completion15 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05102552
Sponsor's protocol ID
817P106
Status last verified
Aug 2022
First submitted
22 Sep 2021
Last updated
30 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing SPN-817, Treatment B, SPN-817, Treatment C and BIS-001, Treatment A in people with Healthy Volunteer, 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 12 inclusion and 33 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 30 Aug 2022. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Relative Bioavailability (time frame: 22 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05102552.

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 30 Aug 2022.

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