Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
- Registration Number
- NCT01527734
- Lead Sponsor
- Wex Pharmaceuticals Inc.
- Brief Summary
The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Normal renal function
Exclusion Criteria
- History of multiple clinically significant drug allergies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo placebo - Tetrodotoxin, TTX Tetrodotoxin -
- Primary Outcome Measures
Name Time Method Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX 26 timepoints over 48 hours PK timepoints occurred at 0,0.33,0.67,1, 1.5,2,4,6,8,10,12,14 and 24 hours after first dose on Days 1 \& 2. Liquid and Lyophilized formulations will be assessed using ANOVA of the T-R ratio based on log-transformed AUC and Cmax values.
- Secondary Outcome Measures
Name Time Method Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX signage of the ICF to Day 10 Safety was assessed through the collection of AE's, concomitant medications, clinical laboratory assessments, neurological assessments and vital signs. Where summary statistics are presented, these will include n, mean, standard deviation, median, minimum, and maximum.
Trial Locations
- Locations (1)
Comprehensive Clinical Research
🇺🇸Tacoma, Washington, United States