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

NCT ID: NCT01490788

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-18
• Study Completion Date: 2011-12-30

Brief Summary

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.

Detailed 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.

Conditions

Healthy

Study Design

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

Study Groups

Treatment A

1 x TNX-102 2.4 mg gelcap under fasting conditions

Group Type: EXPERIMENTAL

Treatment A

Intervention Type: DRUG

TNX-102 2.4 mg - 1 gelcap once under fasting conditions.

Treatment B

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

Group Type: EXPERIMENTAL

Treatment B

Intervention Type: DRUG

Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions

Treatment C

1 x TNX-102 2.4 mg gelcap under fed conditions

Group Type: ACTIVE_COMPARATOR

Treatment C

Intervention Type: DRUG

TNX-102 2.4 mg, 1 gelcap once given under fed conditions.

Interventions

Treatment A

TNX-102 2.4 mg - 1 gelcap once under fasting conditions.

Intervention Type: DRUG

Treatment B

Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions

Intervention Type: DRUG

Treatment C

TNX-102 2.4 mg, 1 gelcap once given under fed conditions.

Intervention Type: DRUG

Other Intervention Names

cyclobenzaprine HCl; cyclobenzaprine HCl; cyclobenzaprine HCl

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 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

PharmaNet

Locations

PharmaNet, Inc.

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

TNX-CY-F101

Identifier Type: -

Identifier Source: org_study_id