Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT01527734|
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Tetrodotoxin Drug: placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||COMPARISON OF THE PHARMACOKINETICS AND SAFETY OF LIQUID (30 µg) AND LYOPHILIZED TETRODOTOXIN (15 µg AND 30 µg) FOLLOWING SINGLE AND TWICE DAILY SUBCUTANEOUS DOSE ADMINISTRATION TO HEALTHY VOLUNTEERS—DETERMINATIONS IN BLOOD AND URINE|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||January 2012|
|Placebo Comparator: Placebo||
1ml once or twice a day for 1 or 2 days.
|Experimental: Tetrodotoxin, TTX||
15ug and 30ug once or twice a day for 1 or 2 days.
- Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX [ Time Frame: 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.
- Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527734
|United States, Washington|
|Comprehensive Clinical Research|
|Tacoma, Washington, United States, 98418|