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Trial record 24 of 49 for:    CYCLOBENZAPRINE

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

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ClinicalTrials.gov Identifier: NCT04164719
Recruitment Status : Active, not recruiting
First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

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
Healthy Subjects Drug: TNX-102 SL Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : October 14, 2019
Estimated Primary Completion Date : December 24, 2019
Estimated Study Completion Date : December 24, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: cyclobenzaprine HCl




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 [ 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)

  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 [ 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)

  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 [ 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)

  4. 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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04164719


Locations
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Canada, Quebec
Canada, Quebec
Quebec City, Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Denis Audet, MD Contract Research Organization

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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04164719     History of Changes
Other Study ID Numbers: TNX-CY-F110
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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