Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose-Proportionality and Food Effect Study of TNX-102 SL

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: NCT04164719
Recruitment Status : Completed
First Posted : November 15, 2019
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE November 13, 2019
First Posted Date  ICMJE November 15, 2019
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE October 14, 2019
Actual Primary Completion Date December 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 2.8 mg under fasting conditions [ Time Frame: Day 1 to Day 6 ]
    Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
  • Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 5.6 mg under fed conditions [ Time Frame: Day 1 to Day 6 ]
    Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
  • Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 2.8 mg versus TNX-102 SL 5.6 mg under fasting conditions [ Time Frame: Day 1 to Day 15 ]
    Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
  • Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg under fasted and fed conditions [ Time Frame: Day 1 to Day 15 ]
    Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Proportionality and Food Effect Study of TNX-102 SL
Official Title  ICMJE A Single-dose, Randomized, Open-label, 3-way Crossover Study to Evaluate the Dose-proportionality and Food Effect of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Subjects
Brief Summary This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Subjects
Intervention  ICMJE Drug: TNX-102 SL
Subjects will place TNX-102 SL sublingual tablets under the tongue until dissolved, and not to crush or chew them
Other Name: cyclobenzaprine HCl
Study Arms  ICMJE
  • Experimental: Treatment A
    TNX-102 SL 2.8 mg, under fasting conditions
    Intervention: Drug: TNX-102 SL
  • Experimental: Treatment B
    TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fasting conditions
    Intervention: Drug: TNX-102 SL
  • Experimental: Treatment C
    TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fed conditions
    Intervention: Drug: TNX-102 SL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2019)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 24, 2019
Actual Primary Completion Date December 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, non-smoker, ≥18 and ≤65 years of age, 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 components, 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 orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04164719
Other Study ID Numbers  ICMJE TNX-CY-F110
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Tonix Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tonix Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Denis Audet, MD Contract Research Organization
PRS Account Tonix Pharmaceuticals, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP