A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single-Dose, Open-Label, Randomized, Three-Way Crossover Study of the Comparative Bioavailability of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets and of the Effect of Food on the Pharmacokinetics of TNX-102 2.4 mg in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>1 x TNX-102 2.4 mg gelcap under fasting conditions | Drug: Treatment A<br>* TNX-102 2.4 mg - 1 gelcap once under fasting conditions.<br>* Other names: cyclobenzaprine HCl;|
| Experimental: Treatment B<br>1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions | Drug: Treatment B<br>* Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions<br>* Other names: cyclobenzaprine HCl;|
| Active Comparator: Treatment C<br>1 x TNX-102 2.4 mg gelcap under fed conditions | Drug: Treatment C<br>* TNX-102 2.4 mg, 1 gelcap once given under fed conditions.<br>* Other names: cyclobenzaprine HCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) |