Healthy SubjectsPhase 1NCT04164719
Dose-Proportionality and Food Effect Study of TNX-102 SL
A Phase 1 study testing TNX-102 SL in people with Healthy Subjects, run by Tonix Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TNX-102 SL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 14 Oct 2019to 24 Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, non-smoker, ≥18 and ≤65 years of age, with Body Mass Index (BMI) >18.5 and <30.0 kg/m2
- Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study
- Capable of consent
Who cannot join
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening
- Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening
- History of allergic reactions to cyclobenzaprine, any of the formulation components, or other related drugs
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration
- Positive pregnancy test at screening
- Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening
Show all 13Show fewer
- History of significant alcohol or drug abuse within one year prior to screening
- Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days prior to the first dosing or concomitant participation in an investigational study involving no drug administration
- Use of medication other than topical products without significant systemic absorption and hormonal contraceptives
- Donation of plasma within 7 days prior to dosing, or significant loss of blood within 54 days of dosing.
- Abnormal hemoglobin and hematocrit levels at screening
- Breast-feeding subject
- Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Randomized, Open-label, 3-way Crossover Study to Evaluate the Dose-proportionality and Food Effect of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Subjects
This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.
- Conditions
- Healthy Subjects
- Being tested
- TNX-102 SL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-102 SLDrug
Also called cyclobenzaprine HCl
Subjects will place TNX-102 SL sublingual tablets under the tongue until dissolved, and not to crush or chew them
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | TNX-102 SL 2.8 mg, under fasting conditions Receives: Drug: TNX-102 SL |
| Treatment B | Experimental | TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fasting conditions Receives: Drug: TNX-102 SL |
| Treatment C | Experimental | TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fed conditions Receives: Drug: TNX-102 SL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 2.8 mg under fasting conditions
Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
Measured: Day 1 to Day 6
Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 5.6 mg under fed conditions
Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
Measured: Day 1 to Day 6
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 2.8 mg versus TNX-102 SL 5.6 mg under fasting conditions
Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
Measured: Day 1 to Day 15
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg under fasted and fed conditions
Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
Measured: Day 1 to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start14 Oct 2019
- Primary completion24 Dec 2019
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis Audet, MD, Principal investigator, Contract Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164719
- Sponsor's protocol ID
- TNX-CY-F110
- Status last verified
- Jan 2020
- First submitted
- 13 Nov 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomized, Open-label, 3-way Crossover Study to Evaluate the Dose-proportionality and Food Effect of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04164719
- Acronym / sponsor ID
- TNX-CY-F110
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 15 Nov 2019 (actual)
- 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.
This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: TNX-102 SLTNX-102 SL 2.8 mg, under fasting conditions |
| Treatment B | Experimental | Drug: TNX-102 SLTNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fasting conditions |
| Treatment C | Experimental | Drug: TNX-102 SLTNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fed conditions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, non-smoker, ≥18 and ≤65 years of age, with Body Mass Index (BMI) >18.5 and <30.0 kg/m2
- Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study
- Capable of consent
Key exclusion criteria (13 listed)
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening
- Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening
- History of allergic reactions to cyclobenzaprine, any of the formulation components, or other related drugs
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration
- Positive pregnancy test at screening
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 |
|---|---|---|
| TNX-102 SLAlso: cyclobenzaprine HClSubjects will place TNX-102 SL sublingual tablets under the tongue until dissolved, and not to crush or chew them | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 2.8 mg under fasting conditions
Time frame: Day 1 to Day 6
Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 5.6 mg under fed conditions
Time frame: Day 1 to Day 6
Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 2.8 mg versus TNX-102 SL 5.6 mg under fasting conditions
Time frame: Day 1 to Day 15
Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg under fasted and fed conditions
Time frame: Day 1 to Day 15
Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
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 6 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Denis Audet, MD principal investigator
Contract Research Organization
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 TNX-102 SL in people with Healthy Subjects, run by Tonix Pharmaceuticals, Inc. at 1 site in Canada.
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 3 inclusion and 13 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 6 Jan 2020. 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 Canada. 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. 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?
Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 2.8 mg under fasting conditions (time frame: Day 1 to Day 6). The study lists 4 primary outcomes in all. 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 6 Jan 2020.