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

NCT ID: NCT04164719

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2019-12-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment A

TNX-102 SL 2.8 mg, under fasting conditions

Group Type: EXPERIMENTAL

TNX-102 SL

Intervention Type: DRUG

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

Treatment B

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

Group Type: EXPERIMENTAL

TNX-102 SL

Intervention Type: DRUG

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

Treatment C

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

Group Type: EXPERIMENTAL

TNX-102 SL

Intervention Type: DRUG

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

Interventions

TNX-102 SL

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

Intervention Type: DRUG

Other Intervention Names

cyclobenzaprine HCl

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tonix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis Audet, MD

Role: PRINCIPAL_INVESTIGATOR

Contract Research Organization

Locations

Canada, Quebec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

TNX-CY-F110

Identifier Type: -

Identifier Source: org_study_id