COMPLETEDPhase 1

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.

Sponsor

Wex Pharmaceuticals Inc.

Enrollment

44 participants

Sites

1 locations

Start Date

December 2011

Completion

January 2012

HealthyTetrodotoxinplacebo

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

1 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 44.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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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.

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

COMPLETEDPhase 1

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.

Sponsor

Wex Pharmaceuticals Inc.

Enrollment

44 participants

Sites

1 locations

Start Date

December 2011

Completion

January 2012

HealthyTetrodotoxinplacebo

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

1 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 44.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

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

26 timepoints over 48 hours

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

all

Healthy Volunteers

Yes

View full criteria

Inclusion Criteria:

* Normal renal function

Exclusion Criteria:

* History of multiple clinically significant drug allergies

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

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

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

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)