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OpenTrials
Completed

NCT Number: NCT01527734

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Comprehensive Clinical Research

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal renal function

Exclusion criteria

  • History of multiple clinically significant drug allergies

Treatment and study plan

Tetrodotoxin

Drug

15ug and 30ug once or twice a day for 1 or 2 days.

Placebo

Drug

1ml once or twice a day for 1 or 2 days.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wex Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
First posted
Feb 7, 2012
Registry last updated
Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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