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NCT04083833 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Wex Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT04083833: Completed Phase 1 study, sponsored by Wex Pharmaceuticals.
NCT04083833 is a Phase 1 study that has completed, run by Wex Pharmaceuticals. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04083833, a Phase 1 study, has completed, sponsored by Wex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
To determine if a single subcutaneous (SC) administration of TTX at various dose levels has an effect on the QT/QTc intervals when assessing concentration QT (C-QT) relationship (i.e., QT/QTc intervals prolongation in relation to plasma levels of TTX) in healthy adult subjects. Secondary: 1. To determine if a single SC administration of TTX at various dose levels has an effect on other important electrocardiogram (ECG) parameters in healthy adult subjects. 2. To demonstrate sensitivity of this QTc assay using moxifloxacin as a positive control. 3. To confirm plasma pharmacokinetic (PK) of a single SC administration of TTX at various dose levels when administered to healthy adult subjects. 4. To determine the overall safety and tolerability of a single SC administration of TTX at various dose levels when administered to healthy adult subjects. Test Product, Dose, Duration, Mode of Administration, and Batch Number: The test product was 30 µg/mL tetrodotoxin (TTX) for injection, Lot No. F141124-001. Subjects were also administered: * Tetrodotoxin matching placebo a sterile 0.9% sodium chloride injection or normal saline for injection, Lot No. 84-093-DK * 400 mg Avelox® (moxifloxacin hydrochloride) tablets, Lot No. BXHJ1S1 * Moxifloxacin matching placebo film-coated tablets, Id.-No.: K15372, Batch No.: C1606007 Treatments were as follows: Treatment Arm (n = 9) Treatment A: (Period 1) A single TTX dose of 15 μg (0.5 mL of TTX 30 μg/mL injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet) Treatment B: (Period 2) A single TTX dose of 30 μg (1 mL of TTX 30 μg/mL injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet) Treatment C: (Period 3) A single TTX dose of 45 μg (1.5 mL of TTX 30 μg/mL injection solution) administered as 2 SC injections with a single oral moxifloxacin matching placebo (1 x placebo tablet) Subjects randomized
Interventions
- DRUG Placebos
- DRUG Tetrodotoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-02-07 |
| Est. Completion | 2018-03-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04083833
The ClinicalTrials.gov registry entry for NCT04083833 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wex Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT04083833 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04083833 about?
NCT04083833 is a clinical study titled "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". To determine if a single subcutaneous (SC) administration of TTX at various dose levels has an effect on the QT/QTc intervals when assessing concentration QT (C-QT) relationship (i.e., QT/QTc intervals prolongation in relation to plasma levels of TTX) in healthy adult subjects. Secondary: 1. To de...
What is the current status of trial NCT04083833?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2018-02-07. Estimated completion is 2018-03-24.
What interventions are being tested in trial NCT04083833?
The interventions under investigation include: Placebos (DRUG), Tetrodotoxin (DRUG).
Who is sponsoring clinical trial NCT04083833?
This trial is sponsored by Wex Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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