Healthy SubjectsPhase 1NCT03443960
Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules
A Phase 1 study testing TNX-102 SL 5.6 mg and Amrix 30 mg in people with Healthy Subjects, run by Tonix Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules), 30 mg. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TNX-102 SL 5.6 mg and Amrix 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2018to 9 Apr 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, non-smoker, ≥18 and ≤75 years of age (Treatment A) or ≥18 and ≤65 years of age (Treatment B), 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 component, 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 dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX® (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions
This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules), 30 mg.
- Conditions
- Healthy Subjects
- Being tested
- TNX-102 SL 5.6 mg, Amrix 30 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-102 SL 5.6 mgDrug
Also called cyclobenzaprine HCl
Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.
Amrix 30 mgDrug
Also called cyclobenzaprine HCl
Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (TNX-102 SL) | Experimental | 2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days Receives: Drug: TNX-102 SL 5.6 mg |
| Treatment B (AMRIX) | Active comparator | 1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days Receives: Drug: Amrix 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose).
Measured: Day 1 to Day 27
Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose).
Measured: Day 1 to Day 27
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed.
Measured: Day 1 to Day 47
Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg
Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose).
Measured: Day 1 to Day 47
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start29 Jan 2018
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443960
- Sponsor's protocol ID
- TNX-CY-F106
- Status last verified
- Apr 2018
- First submitted
- 6 Feb 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX® (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03443960
- Acronym / sponsor ID
- TNX-CY-F106
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 23 Feb 2018 (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, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules), 30 mg.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (TNX-102 SL) | Experimental | Drug: TNX-102 SL 5.6 mg2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days |
| Treatment B (AMRIX) | Active comparator | Drug: Amrix 30 mg1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, non-smoker, ≥18 and ≤75 years of age (Treatment A) or ≥18 and ≤65 years of age (Treatment B), 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 component, 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 SL 5.6 mgAlso: cyclobenzaprine HClSubjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them. | Drug | Treatment A (TNX-102 SL) |
| Amrix 30 mgAlso: cyclobenzaprine HClSubjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it. | Drug | Treatment B (AMRIX) |
Primary outcome
Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
Time frame: Day 1 to Day 27
Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose).
Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
Time frame: Day 1 to Day 27
Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose).
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
Time frame: Day 1 to Day 47
TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed.
Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg
Time frame: Day 1 to Day 47
Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last 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 24 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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 TNX-102 SL 5.6 mg and Amrix 30 mg 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 24 Apr 2018. 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?
Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg (time frame: Day 1 to Day 27). 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 24 Apr 2018.