Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules

Healthy Subjects Clinical Trial

Official title:

A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX® (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443960
• Other study ID #: TNX-CY-F106
• Status: Completed
• Phase: Phase 1
• First received: February 6, 2018
• Last updated: April 23, 2018
• Start date: January 29, 2018
• Est. completion date: April 9, 2018

Study information

• Verified date: April 2018
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules), 30 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female, non-smoker, =18 and =75 years of age (Treatment A) or =18 and =65 years of age (Treatment B), 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 component, 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 dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TNX-102 SL 5.6 mg
Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.
• Amrix 30 mg
Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.

Locations

Country	Name	City	State
Canada	Quebec City	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg	Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose).	Day 1 to Day 27
Primary	Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg	Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose).	Day 1 to Day 27
Primary	Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg	TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed.	Day 1 to Day 47
Primary	Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg	Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose).	Day 1 to Day 47