Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
This study has been completed.
Sponsor:
Wex Pharmaceuticals Inc.
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
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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 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 Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013