Healthy AdultsPhase 1NCT03168022
Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.
A Phase 1 study testing Treatment A and Treatment B in people with Healthy Adults, run by Tonix Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This study is an open-label, 2-way crossover, single-dose study that is being performed to establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers: manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial drug product. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Treatment A and Treatment B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 16 Dec 2015to 26 Jan 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy male or female between 18 and 65 years of age, non-smoker.
- Body mass index >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 hypersensitivity 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 11Show 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
- 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 SINGLE-DOSE, RANDOMIZED, OPEN-LABEL, TWO-WAY CROSSOVER BIOEQUIVALENCE STUDY OF TNX-102 SL (CYCLOBENZAPRINE HCL SUBLINGUAL TABLETS) 2.8 mg FROM TWO MANUFACTURERS IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS
This study is an open-label, 2-way crossover, single-dose study that is being performed to establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers: manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial drug product. This bioequivalence study will confirm (1) the drug product manufactured from these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.
Read the detailed description
This will be a single centre, bioequivalence, open-label, randomized, single-dose, 2-period, 2 sequence, crossover study under fasting conditions.
Potential subjects will be screened by medical and psychiatric history, and laboratory and physical examinations 2 to 30 days prior to drug administration. All eligible subjects will be admitted to the study unit on Day -1, the day prior to dose administration. Baseline values will be considered the last value obtained before dosing for each assessment. On Day 1, the morning after admission, after all pre-dose assessments have been completed and subjects who remain eligible have agreed to continue, subjects will be randomly assigned to study medication and will receive the assigned test drug. Subjects will be required to fast for at least 10 hours prior to dosing until at least 4 hours post-dose.
For each period, subjects will be confined to the study site from at least 10 hours before dosing until after the 24-hour post-dose blood draw. Subjects will come back for all subsequent blood draws. Subjects will be reassessed for eligibility prior to each dosing period.
- Conditions
- Healthy Adults
- Being tested
- Treatment A, Treatment B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Also called cyclobenzaprine HCl
1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.
Treatment BDrug
Also called cyclobenzaprine HCl
1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved. Receives: Drug: Treatment A |
| Treatment B | Experimental | 1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved. Receives: Drug: Treatment B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Plasma Concentration (AUC) of Cyclobenzaprine
Blood samples were collected prior to drug administration and 0.083 (5 min), 0.167 (10 min),0.333 (20 min), 0.500 (30 min), 0.750 (45 min), 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0, and 96.0 hours post-dose in each period.
Measured: 0 to 96 hours
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Treatment A and Treatment B, Administered as 1 x 2.8 mg TNX-102 SL Under Fasting Conditions.
The MedDRA® dictionary was used to classify all TEAEs reported during the study by System Organ Class (SOC) and Preferred Term (PT).
Measured: Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start16 Dec 2015
- Primary completion26 Jan 2016
- Study completion26 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AdultsStudies 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
- 43 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, inVentiv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168022
- Sponsor's protocol ID
- TNX-CY-F105
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2017
- Last updated
- 11 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SINGLE-DOSE, RANDOMIZED, OPEN-LABEL, TWO-WAY CROSSOVER BIOEQUIVALENCE STUDY OF TNX-102 SL (CYCLOBENZAPRINE HCL SUBLINGUAL TABLETS) 2.8 mg FROM TWO MANUFACTURERS IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS
- ClinicalTrials.gov ID
- NCT03168022
- Acronym / sponsor ID
- TNX-CY-F105
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2015 (actual)
- Primary completion
- 26 Jan 2016 (actual)
- Study completion
- 26 Jan 2016 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, 2-way crossover, single-dose study that is being performed to establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers: manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial drug product. This bioequivalence study will confirm (1) the drug product manufactured from these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.
Detailed description
This will be a single centre, bioequivalence, open-label, randomized, single-dose, 2-period, 2 sequence, crossover study under fasting conditions.
Potential subjects will be screened by medical and psychiatric history, and laboratory and physical examinations 2 to 30 days prior to drug administration. All eligible subjects will be admitted to the study unit on Day -1, the day prior to dose administration. Baseline values will be considered the last value obtained before dosing for each assessment. On Day 1, the morning after admission, after all pre-dose assessments have been completed and subjects who remain eligible have agreed to continue, subjects will be randomly assigned to study medication and will receive the assigned test drug. Subjects will be required to fast for at least 10 hours prior to dosing until at least 4 hours post-dose.
For each period, subjects will be confined to the study site from at least 10 hours before dosing until after the 24-hour post-dose blood draw. Subjects will come back for all subsequent blood draws. Subjects will be reassessed for eligibility prior to each dosing period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Treatment A1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved. |
| Treatment B | Experimental | Drug: Treatment B1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female between 18 and 65 years of age, non-smoker.
- Body mass index >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 (11 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 hypersensitivity 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 |
|---|---|---|
| Treatment AAlso: cyclobenzaprine HCl1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved. | Drug | Treatment A |
| Treatment BAlso: cyclobenzaprine HCl1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved. | Drug | Treatment B |
Primary outcome
Mean Plasma Concentration (AUC) of Cyclobenzaprine
Time frame: 0 to 96 hours
Blood samples were collected prior to drug administration and 0.083 (5 min), 0.167 (10 min),0.333 (20 min), 0.500 (30 min), 0.750 (45 min), 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0, and 96.0 hours post-dose in each period.
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Treatment A and Treatment B, Administered as 1 x 2.8 mg TNX-102 SL Under Fasting Conditions.
Time frame: Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)
The MedDRA® dictionary was used to classify all TEAEs reported during the study by System Organ Class (SOC) and Preferred Term (PT).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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
inVentiv
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 Treatment A and Treatment B in people with Healthy Adults, 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 4 inclusion and 11 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 11 Jul 2019. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Plasma Concentration (AUC) of Cyclobenzaprine (time frame: 0 to 96 hours). The study lists 2 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 11 Jul 2019.