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

NCT07413367 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: TNX-CY-F111
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pharmakokinetic; Open Label; Phase 1

Outcome Measures

Primary Outcomes (3)

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

  From dosing day to end of treatment at 16 days

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

  From dosing day to end of treatment at 16 days

• Cmax: Maximum Plasma Concentration

  From dosing day to end of treatment at 16 days

Secondary Outcomes (4)

• Tmax: Time when the maximal concentration is observed

  From dosing day to end of study at 16 days

• T 1/2 el: Terminal Elimination Half Life

  From dosing day to end of study at 16 days

• 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

  From dosing day to end of study at 16 days

• K el: Terminal elimination rate constant

  From dosing day to end of study at 16 days

Study Arms (1)

TNX-102 SL

EXPERIMENTAL

CYCLOBENZAPRINE HYDROCHLORIDE SUBLINGUAL TABLET

Drug: TNX-102 SL Tablet

Interventions

TNX-102 SL Tablet DRUG

CYCLOBENZAPRINE HYDROCHLORIDE SUBLINGUAL TABLET

TNX-102 SL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead
• Syneos Health: collaborator

Study Sites (1)

Syneos Health Clinique, Inc.

Québec, Quebec, G1P 0A2, Canada

Location

Study Officials

• Dan Rudin, MD

  Tonix Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 17, 2026
• Study Start: December 9, 2025
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CA (1)