A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-1… (NCT07413367) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
Canada50 participantsStarted 2025-12-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
What they're measuring
1
AUC0-inf: Area Under the curve from time zero to infinity
Timeframe: 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
Timeframe: From dosing day to end of treatment at 16 days
3
Cmax: Maximum Plasma Concentration
Timeframe: From dosing day to end of treatment at 16 days
. 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.