Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
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
1 other identifier
interventional
44
1 country
1
Brief Summary
The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedFebruary 8, 2012
February 1, 2012
1 month
January 23, 2012
February 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX
signage of the ICF to Day 10
Study Arms (2)
Placebo
PLACEBO COMPARATORTetrodotoxin, TTX
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Normal renal function
You may not qualify if:
- History of multiple clinically significant drug allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Comprehensive Clinical Research
Tacoma, Washington, 98418, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2012
First Posted
February 7, 2012
Study Start
December 1, 2011
Primary Completion
January 1, 2012
Last Updated
February 8, 2012
Record last verified: 2012-02