HealthyPhase 1NCT01527734
Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
A Phase 1 study testing Tetrodotoxin in people with Healthy, run by Wex Pharmaceuticals Inc. at 1 site in United States.
Trial summary
The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tetrodotoxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal renal function
Who cannot join
- History of multiple clinically significant drug allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Clinical Research
Tacoma, Washington, 98418
About this study
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
The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.
- Conditions
- Healthy
- Being tested
- Tetrodotoxin, placebo
- Keywords
- Comparison study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrodotoxinDrug
15ug and 30ug once or twice a day for 1 or 2 days.
placeboDrug
1ml once or twice a day for 1 or 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Tetrodotoxin, TTX | Experimental | Not described Receives: Drug: Tetrodotoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX
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.
Measured: 26 timepoints over 48 hours
Secondary outcomes (1)
Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX
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.
Measured: signage of the ICF to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wex Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527734
- Sponsor's protocol ID
- TTX-CINP-201PK
- Status last verified
- Feb 2012
- First submitted
- 23 Jan 2012
- Last updated
- 8 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01527734
- Acronym / sponsor ID
- TTX-CINP-201PK
- Conditions
- Healthy
- Keywords
- Comparison study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wex Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jan 2012 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo |
| Tetrodotoxin, TTX | Experimental | Drug: Tetrodotoxin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal renal function
Key exclusion criteria (1 listed)
- History of multiple clinically significant drug allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetrodotoxin15ug and 30ug once or twice a day for 1 or 2 days. | Drug | Tetrodotoxin, TTX |
| placebo1ml once or twice a day for 1 or 2 days. | Drug | Placebo |
Primary outcome
Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX
Time frame: 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.
1 secondary outcome
Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX
Time frame: signage of the ICF to Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tetrodotoxin in people with Healthy, run by Wex Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX (time frame: 26 timepoints over 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.