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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wex Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01527734
First received: January 23, 2012
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.


Condition Intervention Phase
Healthy
Drug: Tetrodotoxin
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Wex Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX [ Time Frame: 26 timepoints over 48 hours ] [ Designated as safety issue: No ]
    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:
  • Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX [ Time Frame: signage of the ICF to Day 10 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 44
Study Start Date: December 2011
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal renal function

Exclusion Criteria:

  • History of multiple clinically significant drug allergies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527734

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

Additional Information:
No publications provided

Responsible Party: Wex Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01527734     History of Changes
Other Study ID Numbers: TTX-CINP-201PK
Study First Received: January 23, 2012
Last Updated: February 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Wex Pharmaceuticals Inc.:
Comparison study

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

ClinicalTrials.gov processed this record on August 21, 2014