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

NCT01527734 Phase 1 COMPLETED

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

Details

Lead sponsor	Wex Pharmaceuticals Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	44
Start date	2011-12

Conditions

• Healthy

Interventions

• Tetrodotoxin
• placebo

Primary outcomes

• Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX — 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.

Countries

United States