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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

• Registration Number: NCT01490788
• Lead Sponsor: Tonix Pharmaceuticals, Inc.

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.

Study Timeline

• Study Start: 2011-11-18
• Study First Submitted: 2011-12-07
• Study First Submitted QC: 2011-12-09
• Study First Posted: 2011-12-13
• Primary Completion: 2011-12-30
• Study Completion: 2011-12-30
• Results First Submitted: 2017-08-08
• Results First Submitted QC: 2018-03-05
• Results First Posted: 2018-11-02
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Treatment A	1 x TNX-102 2.4 mg gelcap under fasting conditions
Treatment B	Treatment B	1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions
Treatment C	Treatment C	1 x TNX-102 2.4 mg gelcap under fed conditions

Primary Outcome Measures

Name	Time	Method
Mean Plasma Concentration (AUC) of Cyclobenzaprine	0 to 96 hours	Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.
Incidences of Adverse Events	Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)	Every adverse events occurring during the study period will be reported.

Trial Locations

Locations (1)

PharmaNet, Inc.; 🇨🇦 Québec City, Quebec, Canada