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Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01527734
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Tetrodotoxin Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
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

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: placebo
1ml once or twice a day for 1 or 2 days.
Experimental: Tetrodotoxin, TTX Drug: Tetrodotoxin
15ug and 30ug once or twice a day for 1 or 2 days.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal renal function

Exclusion Criteria:

  • History of multiple clinically significant drug allergies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527734


Locations
United States, Washington
Comprehensive Clinical Research
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Wex Pharmaceuticals Inc.

Additional Information:
Responsible Party: Wex Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01527734     History of Changes
Other Study ID Numbers: TTX-CINP-201PK
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by Wex Pharmaceuticals Inc.:
Comparison study

Additional relevant MeSH terms:
Tetrodotoxin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action