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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04164719
• Other study ID #: TNX-CY-F110
• Status: Completed
• Phase: Phase 1
• Start date: October 14, 2019
• Est. completion date: December 24, 2019

Study information

• Verified date: January 2020
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 24, 2019
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TNX-102 SL
Subjects will place TNX-102 SL sublingual tablets under the tongue until dissolved, and not to crush or chew them

Locations

Country	Name	City	State
Canada	Canada, Quebec	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)	Day 1 to Day 6
Primary	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	Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)	Day 1 to Day 6
Primary	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	Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)	Day 1 to Day 15
Primary	Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg under fasted and fed conditions	Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)	Day 1 to Day 15