Healthy Subjects
Conditions
Brief summary
This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.
Interventions
DRUGTNX-102 SL
Subjects will place TNX-102 SL sublingual tablets under the tongue until dissolved, and not to crush or chew them
Sponsors
Tonix Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, non-smoker, ≥18 and ≤65 years of age, with Body Mass Index (BMI) \>18.5 and \<30.0 kg/m2 * Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study * Capable of consent
Exclusion criteria
* Any clinically significant abnormality or abnormal laboratory test results found during medical screening * Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening * History of allergic reactions to cyclobenzaprine, any of the formulation components, or other related drugs * Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration * Positive pregnancy test at screening * Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening * History of significant alcohol or drug abuse within one year prior to screening * Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days prior to the first dosing or concomitant participation in an investigational study involving no drug administration * Use of medication other than topical products without significant systemic absorption and hormonal contraceptives * Donation of plasma within 7 days prior to dosing, or significant loss of blood within 54 days of dosing. * Abnormal hemoglobin and hematocrit levels at screening * Breast-feeding subject * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 2.8 mg under fasting conditions | Day 1 to Day 6 | Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose) |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 5.6 mg under fed conditions | Day 1 to Day 6 | Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose) |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 2.8 mg versus TNX-102 SL 5.6 mg under fasting conditions | Day 1 to Day 15 | Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose) |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg under fasted and fed conditions | Day 1 to Day 15 | Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose) |
Countries
Canada
Outcome results
None listed