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

NCT03443960 | Completed Phase 1 FDA Drug

• 1 other identifier: TNX-CY-F106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Treatment A (TNX-102 SL)

EXPERIMENTAL

2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days

Drug: TNX-102 SL 5.6 mg

Treatment B (AMRIX)

ACTIVE COMPARATOR

1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days

Drug: Amrix 30 mg

Interventions

TNX-102 SL 5.6 mg DRUG

Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.

Also known as: cyclobenzaprine HCl

Treatment A (TNX-102 SL)

Amrix 30 mg DRUG

Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.

Also known as: cyclobenzaprine HCl

Treatment B (AMRIX)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (1)

Quebec City

Québec, Quebec, G1P 0A2, Canada

Location

MeSH Terms

Interventions

cyclobenzaprine

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 23, 2018
• Study Start: January 29, 2018
• Primary Completion: April 9, 2018
• Study Completion: April 9, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

CA (1)