Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults
Overview[ - collapse ][ - ]
Purpose | 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 TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets). |
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Condition | Healthy Adults |
Intervention | Drug: SL TNX-102 at 2.4 mg Drug: SL TNX-102 at 4.8 mg Drug: SL TNX-102-A at 2.4 mg Drug: Cyclobenzaprine tablets |
Phase | Phase 1 |
Sponsor | Tonix Pharmaceuticals, Inc. |
Responsible Party | Tonix Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier | NCT01689259 |
First Received | September 14, 2012 |
Last Updated | June 6, 2013 |
Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | September 14, 2012 |
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Last Updated Date | June 6, 2013 |
Start Date | September 2012 |
Estimated Primary Completion Date | March 2014 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults |
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Official Title | A Single-Dose, Open-Label, Randomized, Parallel-Design Study of the Comparative Pharmacokinetics and Safety of TNX-102 2.4 mg SL Tablets (With Phosphate) at 2.4 mg and 4.8 mg, TNX-102-A 2.4 mg SL Tablets (Without Phosphate) at 2.4 mg and Cyclobenzaprine 5 mg Oral Tablets in Healthy Adults. |
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 TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Healthy Adults |
Intervention | Drug: SL TNX-102 at 2.4 mg 1 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it. Drug: SL TNX-102 at 4.8 mg 2 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing them. Drug: SL TNX-102-A at 2.4 mg 1 TNX-102-A SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it. Drug: Cyclobenzaprine tablets 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 24 |
Estimated Completion Date | March 2014 |
Estimated Primary Completion Date | December 2013 |
Eligibility Criteria | Inclusion Criteria: - Healthy adults - Male or female - Non-smoker - 18-65 years old - 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01689259 |
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Other Study ID Numbers | TNX-CY-F103 |
Has Data Monitoring Committee | No |
Information Provided By | Tonix Pharmaceuticals, Inc. |
Study Sponsor | Tonix Pharmaceuticals, Inc. |
Collaborators | Not Provided |
Investigators | Study Chair: Seth M. Lederman, MD Tonix Pharmaceuticals, Inc.Study Director: Jeffrey P. Kitrelle, MD Tonix Pharmaceuticals, Inc.Principal Investigator: Denis Audet, MD PharmaNet |
Verification Date | June 2013 |
Locations[ + expand ][ + ]
PharmaNet, Inc. | Quebec City, Quebec, Canada, G1P 0A2 |
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