Clinical trial NCT04164719: Dose-Proportionality and Food Effect Study of TNX-102 SL
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


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

Primary outcomes:
measure: 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
timeFrame: Day 1 to Day 6
measure: 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
timeFrame: Day 1 to Day 6
measure: 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
timeFrame: Day 1 to Day 15
measure: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg under fasted and fed conditions
timeFrame: Day 1 to Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Canada, Quebec
state: Quebec
Study officials:
affiliation: Contract Research Organization
name: Denis Audet, MD
role: PRINCIPAL_INVESTIGATOR
References: