Clinical TrialID 4831
A Phase 1, Single Ascending Dose, Randomized, Double-Blind, Placebo and Positive Controlled Study to Evaluate the Cardiovascular Effect of Tetrodotoxin in Healthy Adult Subjects
NCT04083833
TQT Study
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 4831
- Evidence Id
- 4831
- Core Evidence Id
- 4831
- Source Clinical Trial Id
- 4806
- Herb2 Clinical Trial Id
- HBCT004806
- Nct Id
- NCT04083833
- Title
- A Phase 1, Single Ascending Dose, Randomized, Double-Blind, Placebo and Positive Controlled Study to Evaluate the Cardiovascular Effect of Tetrodotoxin in Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- TQT Study
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
- Intervention
- DRUG: Tetrodotoxin|DRUG: Placebos
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Basic_Science
- Gender
- All
- Age
- Adult
- Enrollment
- 25
- Outcome Measure
- Cardiodynamic, The primary cardiodynamic endpoint was the effect of TTX plasma concentrations on the QTc interval using linear mixed-effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels of interest., 24 hours
- Sponsor Collaborator
- Wex Pharmaceuticals Inc.|Celerion
- Funded By
- INDUSTRY
- Location
- Celerion, Tempe, Arizona, 85283, United States
- Other Id
- TTX-TQT-101
- Start Date
- 2018-02-07
- Primary Completion Date
- 2018-03-24
- Completion Date
- 2018-03-24
- First Posted
- 2019-09-10
- Results First Posted
- Last Update Posted
- 2019-09-10
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04083833
- Title Cn
- Title En
- A Phase 1, Single Ascending Dose, Randomized, Double-Blind, Placebo and Positive Controlled Study to Evaluate the Cardiovascular Effect of Tetrodotoxin in Healthy Adult Subjects
- Bilingual Status
- semi_complete