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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

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ClinicalTrials.gov Identifier: NCT01889173
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : September 26, 2014
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

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).

Condition or disease Intervention/treatment Phase
Healthy Adults Drug: TNX-102 SL Tablets at 2.8 mg Drug: TNX-102-B SL Tablets at 2.8 mg Drug: TNX-102-C SL Tablets at 2.8 mg Drug: Cyclobenzaprine tablets Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Dose, Open-Label, Randomized, Parallel-Design Study Of The Comparative Pharmacokinetics And Safety Of TNX-102 2.8 mg SL Tablets (With Potassium Phosphate) At 2.8 mg, TNX-102-B 2.8 mg SL Tablets (With Sodium Phosphate) At 2.8 mg, TNX-102-C 2.8 mg SL Tablets (With Trisodium Citrate) At 2.8 mg, And Cyclobenzaprine 5 mg Oral Tablets In Healthy Adults
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: TNX-102 SL Tablets at 2.8 mg
1 x TNX-102 SL Tablets (with potassium phosphate) at 2.8 mg
Drug: 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.

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

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

Active Comparator: Cyclobenzaprine tablets
1 x 5 mg cyclobenzaprine oral tablet
Drug: Cyclobenzaprine tablets
1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water




Primary Outcome Measures :
  1. Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine [ Time Frame: 26 time points per period for blood assessment ; 2 pooled analyses in urine. ]
    Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24 and 24-48 hours post-dose.

  2. Safety and tolerability of the 3 formulations of TNX-102 SL Tablets at 2.8 mg [ Time Frame: Continuously until the end (day 3) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month) ]
    Every adverse events occurring during the study period will be reported.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889173


Locations
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Canada, Quebec
PharmaNet, Inc.
Quebec City, Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Study Chair: Seth M. Lederman, MD Tonix Pharmaceuticals, Inc.
Study Director: Jeffrey P. Kitrelle, MD Tonix Pharmaceuticals, Inc.
Principal Investigator: Denis Audet, MD PharmaNet

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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01889173     History of Changes
Other Study ID Numbers: TNX-CY-F104
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Amitriptyline
Cyclobenzaprine
Citric Acid
Sodium Citrate
Potassium phosphate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents
Cariostatic Agents
Protective Agents