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The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Tetrodotoxin, TTX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetrodotoxin | Drug | 15ug and 30ug once or twice a day for 1 or 2 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX | 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. | 26 timepoints over 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX | 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. | signage of the ICF to Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Clinical Research | Tacoma | Washington | 98418 | United States |
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| ID | Term |
|---|---|
| D013779 | Tetrodotoxin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo |
| Drug |
1ml once or twice a day for 1 or 2 days. |
|
| D008387 | Marine Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |