Comparative Bioavailability of TNX-102 and Cyclobenzaprine and Effect of Food on the Pharmacokinetics of TNX-102 in Healthy Adults
|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|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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.|
- 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.
|Study Start Date:||December 2011|
|Study Completion Date:||March 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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.|