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

Sponsor
Tonix Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04164719
Collaborator
(none)
16
Enrollment
1
Location
3
Arms
2.3
Actual Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.

Condition or Disease Intervention/Treatment Phase
  • Drug: TNX-102 SL
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Oct 14, 2019
Actual Primary Completion Date :
Dec 24, 2019
Actual Study Completion Date :
Dec 24, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A

TNX-102 SL 2.8 mg, under fasting conditions

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 Names:
  • cyclobenzaprine HCl

    		•
    Experimental: Treatment B

    TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fasting conditions

    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 Names:
  • cyclobenzaprine HCl

    		•
    Experimental: Treatment C

    TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fed conditions

    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 Names:
  • cyclobenzaprine HCl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [Day 1 to Day 6]

      Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)

    2. 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 [Day 1 to Day 6]

      Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)

    3. 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 [Day 1 to Day 15]

      Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)

    4. Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg under fasted and fed conditions [Day 1 to Day 15]

      Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Canada, Quebec Quebec City Quebec Canada G1P 0A2

    Sponsors and Collaborators

    • Tonix Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Denis Audet, MD, Contract Research Organization

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tonix Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04164719
    Other Study ID Numbers:
    • TNX-CY-F110
    First Posted:
    Nov 15, 2019
    Last Update Posted:
    Jan 6, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cyclobenzaprine

    Study Results

    No Results Posted as of Jan 6, 2020