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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 1 x TNX-102 2.4 mg gelcap under fasting conditions |
|
| Treatment B | Experimental | 1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions |
|
| Treatment C | Active Comparator | 1 x TNX-102 2.4 mg gelcap under fed conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | TNX-102 2.4 mg - 1 gelcap once under fasting conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 96 hours |
| Incidences of Adverse Events | Every adverse events occurring during the study period will be reported. | Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month) |
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Inclusion Criteria: Healthy adults
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis Audet, MD | PharmaNet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PharmaNet, Inc. | Québec | Quebec | G1P 0A2 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A First, Then B, Then C | Single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions) |
| FG001 | Treatment A First, Then C, Then B | Single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions) |
| FG002 | Treatment B First, Then A, Then C | Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions) |
| FG003 | Treatment B First, Then C, Then A | Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions) |
| FG004 | Treatment C First, Then A, Then B | Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions) |
| FG005 | Treatment C First, Then B, Then A | Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All subjects that were randomized to receive all three treatments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | pg.hr/mL | 0 to 96 hours |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg Sullivan, MD | Tonix Pharmaceuticals, Inc. | greg.sullivan@tonixpharma.com |
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| ID | Term |
|---|---|
| C004704 | cyclobenzaprine |
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| Treatment B | Drug | Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions |
|
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| Treatment C | Drug | TNX-102 2.4 mg, 1 gelcap once given under fed conditions. |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Treatment C |
All study subject who were administered one TNX-102 2.4 mg, gelcap under fed conditions during the course of the study. |
|
|
| Primary | Incidences of Adverse Events | Every adverse events occurring during the study period will be reported. | Posted | Count of Participants | Participants | Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month) |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 14 |
| 30 |
| EG001 | Treatment B | All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study. | 0 | 30 | 0 | 30 | 15 | 30 |
| EG002 | Treatment C | All study subject who were administered one TNX-102 2.4 mg gelcap under fed conditions during the course of the study. | 0 | 30 | 0 | 30 | 10 | 30 |
| Abdominal distension | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Blood Pressure increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Ear Discomfort | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Paraesthesia Oral | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA (14.1) | Systematic Assessment |
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| catheter site pain | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Heart Rate increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Mean cell volume increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Dry Throat | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
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| Subjects discontinued due to adverse event |
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