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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec City, Quebec, Canada, G1P 0A2
      • PharmaNet, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Denis Audet, MD, PharmaNet

Study record dates

Study Major Dates

• Study Start: November 18, 2011
• Primary Completion (Actual): December 30, 2011
• Study Completion (Actual): December 30, 2011

Study Registration Dates

• First Submitted: December 7, 2011
• First Submitted That Met QC Criteria: December 9, 2011
• First Posted (Estimate): December 13, 2011

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Neuromuscular Agents; Adrenergic Uptake Inhibitors; Muscle Relaxants, Central; Amitriptyline; Cyclobenzaprine
• Other Study ID Numbers: TNX-CY-F101