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Also known as SL TNX-102 at pH 3.5
SL TNX-102 · 2 trials · 1 indication
Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24, 24-48 and 48-72 hours post-dose.
Every adverse events occurring during the study period will be reported.
Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24, 24-48 and 48-72 hours post-dose.
Every adverse events occurring during the study period will be reported.
| Arm | Type | Description |
|---|---|---|
| SL TNX-102 at 2.4 mg | EXPERIMENTAL | 1 x TNX-102 SL Tablets at 2.4 mg |
| SL TNX-102 at 4.8 mg | EXPERIMENTAL | 2 x TNX-102 SL Tablets at 2.4 mg |
| SL TNX-102-A at 2.4 mg | EXPERIMENTAL | 1 x TNX-102-A (without phosphate) SL Tablet at 2.4 mg |
| Cyclobenzaprine tablets | ACTIVE_COMPARATOR | 1 x 5 mg cyclobenzaprine oral tablet |
| SL TNX-102 at pH 3.5 | EXPERIMENTAL | 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5 |
| SL TNX-102 at pH 7.1 | EXPERIMENTAL | 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1 |
| Cyclobenzaprine IV | ACTIVE_COMPARATOR | 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4 |
| Name | Type | Description |
|---|---|---|
| SL TNX-102 at 2.4 mg | DRUG | 1 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it. |
| SL TNX-102 at 4.8 mg | DRUG | 2 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing them. |
| SL TNX-102-A at 2.4 mg | DRUG | 1 TNX-102-A SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it. |
| Cyclobenzaprine tablets | DRUG | 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water |
| SL TNX-102 2.4 mg at pH 3.5 | DRUG | 1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5, administered as 1 mL held under the tongue for 90 seconds without swallowing |
| SL TNX-102 2.4 mg at pH 7.1 | DRUG | 1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1, administered as 1 mL held under the tongue for 90 seconds without swallowing |
| Cyclobenzaprine Tablet | DRUG | 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water |
| Cyclobenzaprine IV | DRUG | 1 dose of 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4, administered intravenously as a 4 mL bolus injection over 30 seconds |
Inclusion Criteria: * Healthy adults * Male or female * Non-smoker * 18-65 years old * BMI \> 18.5 and \< 30.0 * With medically acceptable form of contraception (female only) * With signed informed consent Exclusion Criteria: * Any clinically significant abnormality including ECG abnormalities or...
SL TNX-102 is an investigational sublingual small molecule developed by Tonix Pharmaceuticals Holding Corp. It is a sublingual formulation studied in healthy adult volunteers in Canada. The program is in Phase 1 clinical development, and the therapeutic indication has not been disclosed.
SL TNX-102 targets 5-HT2A, a serotonin receptor. The compound is a small molecule that acts at this serotonin receptor target. Its sublingual formulation was designed for administration under the tongue, and its pharmacokinetic behavior was compared against oral and intravenous dosing in early studies.
Tonix Pharmaceuticals Holding Corp., which trades under the ticker TNXP, is the developer of SL TNX-102. The company sponsored the Phase 1 pharmacokinetic and bioavailability studies of the sublingual formulation conducted in healthy adult volunteers in Canada.
SL TNX-102 is in Phase 1 clinical development. Both of its recorded Phase 1 trials are completed, and no trials are currently active. The program has not been approved by the FDA, and it remains investigational.
SL TNX-102 has been studied in two completed Phase 1 trials in healthy adults in Canada, each enrolling 24 participants for a total of 48. NCT01689259 compared the pharmacokinetics and safety of TNX-102 SL tablets with cyclobenzaprine oral tablets, and NCT01634412 compared sublingual bioavailability with oral and intravenous cyclobenzaprine.