Clinical trial NCT01889173: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine
timeFrame: 26 time points per period for blood assessment ; 2 pooled analyses in urine.
measure: Safety and tolerability of the 3 formulations of TNX-102 SL Tablets at 2.8 mg
timeFrame: Continuously until the end (day 3) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: PharmaNet, Inc.
state: Quebec
Study officials:
affiliation: Tonix Pharmaceuticals, Inc.
name: Seth M. Lederman, MD
role: STUDY_CHAIR
affiliation: Tonix Pharmaceuticals, Inc.
name: Jeffrey P. Kitrelle, MD
role: STUDY_DIRECTOR
affiliation: PharmaNet
name: Denis Audet, MD
role: PRINCIPAL_INVESTIGATOR
References: