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PharmakokineticPhase 1NCT07413367

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants

A Phase 1 study testing TNX-102 SL Tablet in people with Pharmakokinetic and Open Label, run by Tonix Pharmaceuticals, Inc. at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

TNX-102 SL has recently been approved by the United States (US) Food and Drug Administration (FDA) under the brand name TONMYA for the treatment of fibromyalgia. Fibromyalgia is a long-lasting condition that causes pain all over the body, along with feeling tired and not sleeping well. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pharmakokinetic, Open Label, Phase 1
What is being tested?
TNX-102 SL Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
9 Dec 2025to 10 Feb 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female, with body mass index (BMI) >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
  • Group 1 non-elderly participants must be ≥18 and ≤45 years of age.
  • Group 2 elderly participants must be ≥65 years of age.
  • Healthy, or with stable chronic illness not contraindicated for cyclobenzaprine use for Group 2 elderly participants only (i.e., under stable treatment with the same medication for at least 3 months, with no change in dosage for at least 14 days before admission and no expected change throughout the study, and with medication that is not contraindicated and will not interfere in the PK or the assay of the administered cyclobenzaprine) as defined by:
  • the absence of clinically significant illness and surgery within 4 weeks prior to admission.
  • the absence of clinically significant history of neurological, endocrinological (including hyperthyroidism), cardiovascular (including significant arrhythmias, heart block, conduction disturbances, and congestive heart failure), respiratory, hematological, immunological, psychiatric (including history of previous suicidal ideation or behaviors), gastrointestinal (including absorption or obstructive disorders), renal (including urinary retention), hepatic (including cholestasis), and metabolic disease, with the exception of findings in Group 2 elderly participants that in the opinion of the Investigator are consistent with participant's normal aging and are not contraindicated for cyclobenzaprine use.
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  • the absence of clinically significant history of angle-closure glaucoma or increased intraocular pressure.
  • Estimated glomerular filtration rate (eGFR; using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) ≥60 mL/min/1.73 m2 at screening and/or Day -1.
  • Female participants of non-childbearing potential must be:
  • post-menopausal (spontaneous amenorrhea for at least 12 months prior to admission) with confirmation by documented follicle-stimulating hormone (FSH) levels ≥40 IU/L; or
  • surgically sterile (bilateral oophorectoy, bilateral salpingectomy, hysterectomy or tubal ligation) at least 3 months prior to admission.
  • Female participants of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for at least 3 months prior to admission) must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after dosing: a. simultaneous use of hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to admission (must agree to use the same contraceptive throughout the study) and condom for the male partner; b. simultaneous use of diaphragm or cervical cap with spermicide and condom for the male partner, started at least 21 days prior to admission.
  • Willing to take off dentures or mouth piercing or any other removable oral appliance at the time of dosing, if applicable.
  • Able to understand the study procedures and provide signed informed consent to participate in the study.

Who cannot join

  • Any clinically significant abnormal finding at physical examination at screening and/or Day -1.
  • C-SSRS score above Type 1 ideation.
  • Clinically significant abnormal laboratory test results at screening and/or Day -1; or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody at screening.
  • Use of tobacco or nicotine products within 3 months prior to screening.
  • Positive pregnancy test at screening and/or Day -1; or lactating female participant.
  • Positive urine drug screen, urine cotinine test, or alcohol breath test at screening and/or Day -1.
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  • History or known allergic reactions to cyclobenzaprine or other related drugs, or to any excipient in the formulation.
  • History of anaphylaxis reaction, a documented hypersensitivity reaction, or a clinically significant reaction to any drug.
  • Clinically significant ECG abnormalities or vital signs abnormalities for Group 1 non-elderly participants (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 50 or over 90 mmHg, or HR less than 50 or over 100 bpm) or vital signs abnormalities for Group 2 elderly participants (systolic BP lower than 90 or over 150 mmHg, diastolic BP lower than 50 or over 95 mmHg, or HR less than 50 or over 100 bpm) at screening and/or Day -1.
  • History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
  • History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
  • History or current evidence of oral neoplasm or leukoplakia, history of salivary infections or stones, or presence of any other abnormality involving the oral cavity that, in the opinion of the Investigator, might interfere with the tolerability of study drug or the evaluation of administration site reactions.
  • Use of medications for the timeframes specified below:
  • electroconvulsive therapy (ECT) or any antipsychotics (depot) within 6 months prior to screening; antiparkinsonian, anticonvulsant, or antidepressant medications within 30 days prior to screening; typical and atypical antipsychotics (non-depot) or lithium within 30 days prior to screening; tramadol, meperidine, or verapamil within 30 days prior to screening;
  • depot injection or implant (other than hormonal contraceptives) within 3 months prior to admission;
  • monoamine oxidase inhibitors (MAOIs) within 30 days prior to admission;
  • any drug known to induce or inhibit hepatic drug metabolism, including St. John's wort, within 30 days prior to admission;
  • prescription medications within 14 days prior to admission;
  • any vaccine, including COVID-19 vaccine, within 14 days prior to admission; g. over-the-counter (OTC) medications and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to admission. EXCEPTIONS* include: For Group 2 elderly participants only: stable medications (as defined in Inclusion Criteria no.3); and OTC or natural health products used as part of routine care that have been approved by the Investigator in agreement with Sponsor. For both Group 1 non-elderly participants and Group 2 elderly participants: medications required for the medical management of an AE, occasional use of acetaminophen (up to 2 g daily) or nonsteroidal anti-inflammatory drugs (NSAIDs, up to 1.2 g daily); hormonal contraceptives; and medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or participant safety (e.g., topical drug products without significant systemic absorption). *NOTE: Any exceptions allowed must be approved by the Investigator in agreement with Sponsor, unless deemed by the Investigator as required for the immediate safety of the participant.
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to admission, administration of a biological product in the context of a clinical research study within 90 days prior to admission, or concomitant participation in an investigational study involving no drug or device administration.
  • Donation of plasma within 7 days prior to admission or donation or loss of 500 mL or more of whole blood within 8 weeks prior to admission.
  • Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.
  • Any minor dental procedures (other than routine cleaning) including teeth whitening within 2 weeks prior to admission and/or any major dental procedures within 3 months prior to admission. Participants will also refrain from undergoing any elective minor or major dental procedures throughout the study.
  • Inability to be venipunctured and/or tolerate catheter venous access.
  • Previous exposure to cyclobenzaprine within 30 days prior to screening.
  • Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Syneos Health Clinique, Inc.

    Québec, Quebec, G1P 0A2

Other trials in Canada

About this study

TNX-102 SL has recently been approved by the United States (US) Food and Drug Administration (FDA) under the brand name TONMYA for the treatment of fibromyalgia. Fibromyalgia is a long-lasting condition that causes pain all over the body, along with feeling tired and not sleeping well. TNX-102 SL is not approved for any conditions in Canada.

The study looks at the safety and blood levels of a study drug called TNX-102 SL [cyclobenzaprine hydrochloride (HCl) sublingual (SL) tablets], taken under the tongue, and compares it in non-elderly and elderly male and female participants.

Being tested
TNX-102 SL Tablet

What participants receive

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

  • TNX-102 SL TabletDrug

    CYCLOBENZAPRINE HYDROCHLORIDE SUBLINGUAL TABLET

Study groups in NCT07413367
Study groupRoleWhat they receive
TNX-102 SLExperimentalCYCLOBENZAPRINE HYDROCHLORIDE SUBLINGUAL TABLET
Receives: Drug: TNX-102 SL Tablet

What is being measured

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

  1. AUC0-inf: Area Under the curve from time zero to infinity

    Measured: From dosing day to end of treatment at 16 days

  2. AUC0-t: Area Under the Curve from time zero to the last measurable concentration

    Measured: From dosing day to end of treatment at 16 days

  3. Cmax: Maximum Plasma Concentration

    Measured: From dosing day to end of treatment at 16 days

Secondary outcomes (4)

  1. Tmax: Time when the maximal concentration is observed

    Measured: From dosing day to end of study at 16 days

  2. T 1/2 el: Terminal Elimination Half Life

    Measured: From dosing day to end of study at 16 days

  3. Residual Area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as [1 - (AUC0-t/AUC0-inf)] x 100

    Measured: From dosing day to end of study at 16 days

  4. K el: Terminal elimination rate constant

    Measured: From dosing day to end of study at 16 days

Timeline

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

  1. First posted17 Feb 2026
  2. Study start9 Dec 2025
  3. Primary completion10 Feb 2026 (estimated)
  4. Study completion10 Feb 2026 (estimated)

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
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07413367
Sponsor's protocol ID
TNX-CY-F111
Status last verified
Feb 2026
First submitted
26 Jan 2026
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TNX-102 SL Tablet in people with Pharmakokinetic and Open Label, run by Tonix Pharmaceuticals, Inc. at 1 site in Canada.

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 14 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. 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 Canada. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

AUC0-inf: Area Under the curve from time zero to infinity (time frame: From dosing day to end of treatment at 16 days). The study lists 3 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 NCT07413367.

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 17 Feb 2026.

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