Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults

NCT ID: NCT01889173

Last Updated: 2014-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-03-31

Brief Summary

Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).

Conditions

Healthy Adults

Study Design

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

Study Groups

TNX-102 SL Tablets at 2.8 mg

1 x TNX-102 SL Tablets (with potassium phosphate) at 2.8 mg

Group Type: EXPERIMENTAL

TNX-102 SL Tablets at 2.8 mg

Intervention Type: DRUG

1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.

TNX-102-B SL Tablets at 2.8 mg

1 x TNX-102-B SL Tablets (with sodium phosphate) at 2.8 mg

Group Type: EXPERIMENTAL

TNX-102-B SL Tablets at 2.8 mg

Intervention Type: DRUG

1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.

TNX-102-C SL Tablets at 2.8 mg

1 x TNX-102-C SL Tablets (with trisodium citrate) at 2.8 mg

Group Type: EXPERIMENTAL

TNX-102-C SL Tablets at 2.8 mg

Intervention Type: DRUG

1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.

Cyclobenzaprine tablets

1 x 5 mg cyclobenzaprine oral tablet

Group Type: ACTIVE_COMPARATOR

Cyclobenzaprine tablets

Intervention Type: DRUG

1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water

Interventions

TNX-102 SL Tablets at 2.8 mg

1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.

Intervention Type: DRUG

TNX-102-B SL Tablets at 2.8 mg

1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.

Intervention Type: DRUG

TNX-102-C SL Tablets at 2.8 mg

1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.

Intervention Type: DRUG

Cyclobenzaprine tablets

1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adults
• Male or female
• 18-65 years old
• Non-smoker
• BMI > 18.5 and < 30.0
• With medically acceptable form of contraception (female only)
• With signed informed consent

Exclusion Criteria

• Any clinically significant abnormality including ECG abnormalities or vital sign abnormalities (systolic blood pressure < 90 or > 140 mmHg,
• Diastolic blood pressure lower < 50 or > 90 mmHg, or heart rate < 50 or > 100 BPM)
• Any abnormal laboratory test (including positivity for Hep B, Hep C, HIV, and
• Hemoglobin < 128 g/L (males) or < 115 g/L (females) and hematocrit < 0.37 L/L (males) or < 0.32 L/L (females))
• 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: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tonix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seth M. Lederman, MD

Role: STUDY_CHAIR

Tonix Pharmaceuticals, Inc.

Jeffrey P. Kitrelle, MD

Role: STUDY_DIRECTOR

Tonix Pharmaceuticals, Inc.

Denis Audet, MD

Role: PRINCIPAL_INVESTIGATOR

PharmaNet

Locations

PharmaNet, Inc.

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

TNX-CY-F104

Identifier Type: -

Identifier Source: org_study_id