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
Public ClinicalTrials.gov record NCT04083833. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 to the Control Arm were further randomized to receive 1 of 2 treatment sequences (Treatment Sequence DEF \[n = 8\] and Treatment Sequence GHI \[n = 8\]): Control Arm (n = 16) Treatment D: (Period 1) A single matching-TTX placebo (0.5 mL of placebo injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet) Treatment E: (Period 2) A single matching-TTX placebo (1 mL of placebo injection solution) administered as 1 SC injection with a single oral 400 mg moxifloxacin (1 x 400 mg tablet) Treatment F: (Period 3) A single matching-TTX placebo (1.5 mL of placebo injection solution) administered as 2 SC injections with a single oral moxifloxacin matching placebo (1 x placebo tablet) Treatment G: (Period 1) A single matching-TTX placebo (0.5 mL of placebo injection solution) administered as 1 SC injection with a single oral 400 mg moxifloxacin (1 x 400 mg tablet) Treatment H: (Period 2) A single matching-TTX placebo (1 mL of placebo injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet) Treatment I: (Period 3) A single matching-TTX placebo (1.5 mL of placebo injection solution) administered as 2 SC injections with a single oral 400 mg moxifloxacin (1 x 400 mg tablet) All oral study drugs were administered with approximately 240 mL of water.
Study identification
- NCT ID
- NCT04083833
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 6, 2018
- Primary completion
- Mar 23, 2018
- Completion
- Mar 23, 2018
- Last update posted
- Sep 9, 2019
2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04083833, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2019 · Synced Sep 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04083833 live on ClinicalTrials.gov.