A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.

Tonix Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment A; Drug: Treatment C; Drug: Treatment B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01490788

TNX-CY-F101

Details and patient eligibility

About

The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Full description

Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Healthy adults

• Male or female
• Non-smoker
• 18-55 years old
• BMI > 18.5 and < 30.0
• With medically acceptable form of contraception (female only).

Exclusion Criteria:

• Any clinically significant abnormality or vital sign abnormalities
• Any abnormal laboratory test
• History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
• Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
• Positive pregnancy test, breastfeeding or lactating
• Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
• Participation in an investigational study within 30 days prior to dosing
• Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of > 499 mL (within 56 days) prior to dosing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Treatment A

Experimental group

Description:

1 x TNX-102 2.4 mg gelcap under fasting conditions

Treatment:

Drug: Treatment A

Treatment B

Experimental group

Description:

1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions

Treatment:

Drug: Treatment B

Treatment C

Active Comparator group

Description:

1 x TNX-102 2.4 mg gelcap under fed conditions

Treatment:

Drug: Treatment C