Comparative Bioavailability of TNX-102 and Cyclobenzaprine and Effect of Food on the Pharmacokinetics of TNX-102 in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT01490788|
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : September 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: TNX-102 2.4 mg, Fasting conditions Drug: TNX-102 2.4 mg, Fed conditions Drug: Cyclobenzaprine 5 mg, Fasting conditions||Phase 1|
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. Employing a proprietary mixture of approved lipids with cyclobenzaprine, TNX-102, is designed to provide predictable absorption of cyclobenzaprine and to result in increased dosage precision and decreased potential for morning grogginess.
As a first step in the development of TNX-102 in the treatment of fibromyalgia, the present 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Dose, Open-Label, Randomized, Three-Way Crossover Study of the Comparative Bioavailability of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets and of the Effect of Food on the Pharmacokinetics of TNX-102 in Healthy Adults.|
|Study Start Date :||December 2011|
|Primary Completion Date :||September 2013|
|Study Completion Date :||March 2014|
Experimental: TNX-102 FAST
2.4 mg gelcap once
Drug: TNX-102 2.4 mg, Fasting conditions
TNX-102 2.4 mg - 1 gelcap once under fasting conditions.
Experimental: TNX-102 FED
2.4 mg gelcap once
Drug: TNX-102 2.4 mg, Fed conditions
TNX-102 2.4 mg, 1 gelcap once given under fed conditions.
Active Comparator: cyclobenzaprine FAST
generic cyclobenzaprine 5 mg tablet once or FLEXERIL 5 mg tablet once
Drug: Cyclobenzaprine 5 mg, Fasting conditions
Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions
- Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine [ Time Frame: 23 time points per period for blood assessment ; 4 pooled analyses in urine, safety monitoring throughout the shoe study period.. ]Blood samples will be taken per period: within 30 minutes pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4,4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 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, 24-48, 48-72, and 72-96 hours post-dose.
- Safety and tolerability of TNX-102 2.4 mg [ Time Frame: 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.
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): NCT01490788
|Québec City, Quebec, Canada, G1P 0A2|
|Principal Investigator:||Denis Audet, MD||PharmaNet|
|Study Chair:||Seth M. Lederman, MD||Tonix Pharmaceuticals, Inc.|
|Study Director:||Jeffrey P. Kitrelle, MD||Tonix Pharmaceuticals, Inc.|