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

Tonix Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: TNX-102 SL

Study type: Interventional

Funder types: Industry

Identifiers

NCT04164719

TNX-CY-F110

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Treatment A

Experimental group

Description:

TNX-102 SL 2.8 mg, under fasting conditions

Treatment:

Drug: TNX-102 SL

Treatment B

Experimental group

Description:

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

Treatment:

Drug: TNX-102 SL

Treatment C

Experimental group

Description:

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

Treatment:

Drug: TNX-102 SL