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

NCT04164719 | Completed Phase 1 FDA Drug

• 1 other identifier: TNX-CY-F110
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Treatment A

EXPERIMENTAL

TNX-102 SL 2.8 mg, under fasting conditions

Drug: TNX-102 SL

Treatment B

EXPERIMENTAL

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

Drug: TNX-102 SL

Treatment C

EXPERIMENTAL

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

Drug: TNX-102 SL

Interventions

TNX-102 SL DRUG

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

Also known as: cyclobenzaprine HCl

Treatment A; Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (1)

Canada, Quebec

Québec, Quebec, G1P 0A2, Canada

Location

MeSH Terms

Interventions

cyclobenzaprine

Study Officials

• Denis Audet, MD

  Contract Research Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: October 14, 2019
• Primary Completion: December 24, 2019
• Study Completion: December 24, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)