Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03443960
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: TNX-102 SL 5.6 mg Drug: Amrix 30 mg Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 29, 2018
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A (TNX-102 SL)
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
Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.
Other Name: cyclobenzaprine HCl

Active Comparator: Treatment B (AMRIX)
1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days
Drug: 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.
Other Name: cyclobenzaprine HCl




Primary Outcome Measures :
  1. Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg [ Time Frame: Day 1 to Day 27 ]
    Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose).

  2. Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg [ Time Frame: Day 1 to Day 27 ]
    Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose).

  3. Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg [ Time Frame: Day 1 to Day 47 ]
    TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed.

  4. Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg [ Time Frame: Day 1 to Day 47 ]
    Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443960


Locations
Layout table for location information
Canada, Quebec
Quebec City
Quebec City, Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.

Layout table for additonal information
Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03443960     History of Changes
Other Study ID Numbers: TNX-CY-F106
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Amitriptyline
Cyclobenzaprine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents