Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules

Tonix Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: TNX-102 SL 5.6 mg; Drug: Amrix 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03443960

TNX-CY-F106

Details and patient eligibility

About

This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules), 30 mg.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, non-smoker, ≥18 and ≤75 years of age (Treatment A) or ≥18 and ≤65 years of age (Treatment B), 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 component, 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 dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Treatment A (TNX-102 SL)

Experimental group

Description:

2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days

Treatment:

Drug: TNX-102 SL 5.6 mg

Treatment B (AMRIX)

Active Comparator group

Description:

1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days

Treatment:

Drug: Amrix 30 mg