Healthy
Conditions
Brief summary
The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.
Detailed description
Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.
Interventions
DRUGTreatment A
TNX-102 2.4 mg - 1 gelcap once under fasting conditions.
DRUGTreatment B
Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions
DRUGTreatment C
TNX-102 2.4 mg, 1 gelcap once given under fed conditions.
Sponsors
Tonix Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adults * Male or female * Non-smoker * 18-55 years old * BMI \> 18.5 and \< 30.0 * With medically acceptable form of contraception (female only).
Exclusion criteria
* Any clinically significant abnormality or vital sign abnormalities * Any abnormal laboratory test * History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests * Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication * Positive pregnancy test, breastfeeding or lactating * Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors * Participation in an investigational study within 30 days prior to dosing * Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of \> 499 mL (within 56 days) prior to dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Plasma Concentration (AUC) of Cyclobenzaprine | 0 to 96 hours | Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period. |
| Incidences of Adverse Events | Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month) | Every adverse events occurring during the study period will be reported. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All subjects that were randomized to receive all three treatments. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Region of Enrollment Canada | 30 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 14 / 30 | 15 / 30 | 10 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Incidences of Adverse Events
Every adverse events occurring during the study period will be reported.
Time frame: Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A | Incidences of Adverse Events | Subjects with Serious Adverse Events | 0 Participants |
| Treatment A | Incidences of Adverse Events | Subjects with Treatment-Emergent Adverse Events | 14 Participants |
| Treatment A | Incidences of Adverse Events | Subjects discontinued due to adverse event | 0 Participants |
| Treatment B | Incidences of Adverse Events | Subjects with Serious Adverse Events | 0 Participants |
| Treatment B | Incidences of Adverse Events | Subjects with Treatment-Emergent Adverse Events | 15 Participants |
| Treatment B | Incidences of Adverse Events | Subjects discontinued due to adverse event | 0 Participants |
| Treatment C | Incidences of Adverse Events | Subjects with Treatment-Emergent Adverse Events | 10 Participants |
| Treatment C | Incidences of Adverse Events | Subjects discontinued due to adverse event | 0 Participants |
| Treatment C | Incidences of Adverse Events | Subjects with Serious Adverse Events | 0 Participants |
Primary
Mean Plasma Concentration (AUC) of Cyclobenzaprine
Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.
Time frame: 0 to 96 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment A | Mean Plasma Concentration (AUC) of Cyclobenzaprine | 47,074.19 pg.hr/mL |
| Treatment B | Mean Plasma Concentration (AUC) of Cyclobenzaprine | 94,874.26 pg.hr/mL |
| Treatment C | Mean Plasma Concentration (AUC) of Cyclobenzaprine | 50,263.16 pg.hr/mL |