Healthy AdultsPhase 1NCT01634412
Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults
A Phase 1 study testing SL TNX-102 2.4 mg at pH 3.5, SL TNX-102 2.4 mg at pH 7.1 and Cyclobenzaprine Tablet in people with Healthy Adults, run by Tonix Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. 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?
- SL TNX-102 2.4 mg at pH 3.5, SL TNX-102 2.4 mg at pH 7.1 and Cyclobenzaprine Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jan 2014
- 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
- 18-65 years old
- BMI > 18.5 and < 30.0
- With medically acceptable form of contraception (female only)
- With signed informed consent
Who cannot join
- Any clinically significant abnormality including ECG abnormalities or vital sign abnormalities (systolic blood pressure < 90 or > 140 mmHg, diastolic blood pressure lower < 50 or > 90 mmHg, or heart rate < 50 or > 100 BPM)
- Any abnormal laboratory test (including positivity for Hep B, Hep C, HIV, and Hemoglobin < 128 g/L (males) or < 115 g/L (females) and hematocrit < 0.37 L/L (males) or < 0.32 L/L (females))
- History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
- Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
- Positive pregnancy test, breastfeeding or lactating
- Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
- Participation in an investigational study within 30 days prior to dosing
- Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within30 days), or of > 499 mL (within 56 days) prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Open-Label, Randomized Study of the Comparative Pharmacokinetics of Sublingual TNX-102 2.4 mg at pH 3.5 and 7.1, Oral Cyclobenzaprine 5 mg Tablets, and Intravenous Cyclobenzaprine 2.4 mg in Healthy Adults
Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1 and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and cyclobenzaprine (5 mg tablets, or 2.4 mg iv).
- Conditions
- Healthy Adults
- Being tested
- SL TNX-102 2.4 mg at pH 3.5, SL TNX-102 2.4 mg at pH 7.1, Cyclobenzaprine Tablet, Cyclobenzaprine IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL TNX-102 2.4 mg at pH 3.5Drug
1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5, administered as 1 mL held under the tongue for 90 seconds without swallowing
SL TNX-102 2.4 mg at pH 7.1Drug
1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1, administered as 1 mL held under the tongue for 90 seconds without swallowing
Cyclobenzaprine TabletDrug
1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
Cyclobenzaprine IVDrug
1 dose of 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4, administered intravenously as a 4 mL bolus injection over 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| SL TNX-102 at pH 3.5 | Experimental | 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5 Receives: Drug: SL TNX-102 2.4 mg at pH 3.5 |
| SL TNX-102 at pH 7.1 | Experimental | 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1 Receives: Drug: SL TNX-102 2.4 mg at pH 7.1 |
| Cyclobenzaprine tablets | Active comparator | 5 mg cyclobenzaprine tablet once Receives: Drug: Cyclobenzaprine Tablet |
| Cyclobenzaprine IV | Active comparator | 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4 Receives: Drug: Cyclobenzaprine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine
Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24, 24-48 and 48-72 hours post-dose.
Measured: 27 time points per period for blood assessment ; 3 pooled analyses in urine.
Safety and tolerability of sublingual TNX-102 2.4 mg at pH 3.5 and pH 7.1.
Every adverse events occurring during the study period will be reported.
Measured: Continuously until the end (day 4) of the study period + Telephone follow-up 7-13 days after dosing (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 posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seth M. Lederman, MD, Study chair, Tonix Pharmaceuticals, Inc.Jeffrey P. Kitrelle, MD, Study director, Tonix Pharmaceuticals, Inc.Denis Audet, MD, Principal investigator, PharmaNet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634412
- Sponsor's protocol ID
- TNX-CY-F102
- Status last verified
- Sep 2014
- First submitted
- 25 Jun 2012
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized Study of the Comparative Pharmacokinetics of Sublingual TNX-102 2.4 mg at pH 3.5 and 7.1, Oral Cyclobenzaprine 5 mg Tablets, and Intravenous Cyclobenzaprine 2.4 mg in Healthy Adults
- ClinicalTrials.gov ID
- NCT01634412
- Acronym / sponsor ID
- TNX-CY-F102
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Jul 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.
Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1 and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and cyclobenzaprine (5 mg tablets, or 2.4 mg iv).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SL TNX-102 at pH 3.5 | Experimental | Drug: SL TNX-102 2.4 mg at pH 3.52.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5 |
| SL TNX-102 at pH 7.1 | Experimental | Drug: SL TNX-102 2.4 mg at pH 7.12.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1 |
| Cyclobenzaprine tablets | Active comparator | Drug: Cyclobenzaprine Tablet5 mg cyclobenzaprine tablet once |
| Cyclobenzaprine IV | Active comparator | Drug: Cyclobenzaprine IV2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Non-smoker
- 18-65 years old
- BMI > 18.5 and < 30.0
- With medically acceptable form of contraception (female only)
Key exclusion criteria (8 listed)
- Any clinically significant abnormality including ECG abnormalities or vital sign abnormalities (systolic blood pressure < 90 or > 140 mmHg, diastolic blood pressure lower < 50 or > 90 mmHg, or heart rate < 50 or > 100 BPM)
- Any abnormal laboratory test (including positivity for Hep B, Hep C, HIV, and Hemoglobin < 128 g/L (males) or < 115 g/L (females) and hematocrit < 0.37 L/L (males) or < 0.32 L/L (females))
- History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
- Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
- Positive pregnancy test, breastfeeding or lactating
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 |
|---|---|---|
| SL TNX-102 2.4 mg at pH 3.51 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5, administered as 1 mL held under the tongue for 90 seconds without swallowing | Drug | SL TNX-102 at pH 3.5 |
| SL TNX-102 2.4 mg at pH 7.11 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1, administered as 1 mL held under the tongue for 90 seconds without swallowing | Drug | SL TNX-102 at pH 7.1 |
| Cyclobenzaprine Tablet1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water | Drug | Cyclobenzaprine tablets |
| Cyclobenzaprine IV1 dose of 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4, administered intravenously as a 4 mL bolus injection over 30 seconds | Drug | Cyclobenzaprine IV |
Primary outcome
• Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine
Time frame: 27 time points per period for blood assessment ; 3 pooled analyses in urine.
Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24, 24-48 and 48-72 hours post-dose.
Safety and tolerability of sublingual TNX-102 2.4 mg at pH 3.5 and pH 7.1.
Time frame: Continuously until the end (day 4) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month)
Every adverse events occurring during the study period will be reported.
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 26 Sep 2014.
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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.
Seth M. Lederman, MD study chair
Tonix Pharmaceuticals, Inc.
Jeffrey P. Kitrelle, MD study director
Tonix Pharmaceuticals, Inc.
Denis Audet, MD principal investigator
PharmaNet
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 SL TNX-102 2.4 mg at pH 3.5, SL TNX-102 2.4 mg at pH 7.1 and Cyclobenzaprine Tablet 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 6 inclusion and 8 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 26 Sep 2014. 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?
• Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine (time frame: 27 time points per period for blood assessment ; 3 pooled analyses in urine.). 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 26 Sep 2014.