HealthyPhase 1NCT01490788

A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by Tonix Pharmaceuticals, Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions. 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?: Treatment A, Treatment B and Treatment C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteCanada
Study dates: 18 Nov 2011to 30 Dec 2011
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female
Non-smoker
18-55 years old
BMI > 18.5 and < 30.0
With medically acceptable form of contraception (female only).

Who cannot join

Any clinically significant abnormality or vital sign abnormalities
Any abnormal laboratory test
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 (within 30 days), or of > 499 mL (within 56 days) prior to dosing.

Trial locations and contacts

1 site in 1 country.

Canada1 site

PharmaNet, Inc.
Québec, Quebec, G1P 0A2

Other trials in Canada

About this study

Official title: A Single-Dose, Open-Label, Randomized, Three-Way Crossover Study of the Comparative Bioavailability of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets and of the Effect of Food on the Pharmacokinetics of TNX-102 2.4 mg in Healthy Adults

The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Read the detailed description

Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Conditions: Healthy
Being tested: Treatment A, Treatment B, Treatment C

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
TNX-102 2.4 mg - 1 gelcap once under fasting conditions.
Treatment BDrug
Also called cyclobenzaprine HCl
Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions
Treatment CDrug
Also called cyclobenzaprine HCl
TNX-102 2.4 mg, 1 gelcap once given under fed conditions.

Study groups in NCT01490788
Study group	Role	What they receive
Treatment A	Experimental	1 x TNX-102 2.4 mg gelcap under fasting conditions Receives: Drug: Treatment A
Treatment B	Experimental	1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions Receives: Drug: Treatment B
Treatment C	Active comparator	1 x TNX-102 2.4 mg gelcap under fed conditions Receives: Drug: Treatment C

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 pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.
Measured: 0 to 96 hours
Incidences of Adverse Events
Every adverse events occurring during the study period will be reported.
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.

18 Nov 201130 Dec 2011

First posted13 Dec 2011 (estimated)
Study start18 Nov 2011
Primary completion30 Dec 2011
Study completion30 Dec 2011

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 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01490788
Sponsor's protocol ID: TNX-CY-F101
Status last verified: Sep 2019
First submitted: 7 Dec 2011
Last updated: 11 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
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

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Open-Label, Randomized, Three-Way Crossover Study of the Comparative Bioavailability of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets and of the Effect of Food on the Pharmacokinetics of TNX-102 2.4 mg in Healthy Adults
ClinicalTrials.gov ID: NCT01490788
Acronym / sponsor ID: TNX-CY-F101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 18 Nov 2011
Primary completion: 30 Dec 2011 (actual)
Study completion: 30 Dec 2011 (actual)
First posted: 13 Dec 2011 (estimated)
Results: Posted 2 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment A	Experimental	Drug: Treatment A1 x TNX-102 2.4 mg gelcap under fasting conditions
Treatment B	Experimental	Drug: Treatment B1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions
Treatment C	Active comparator	Drug: Treatment C1 x TNX-102 2.4 mg gelcap under fed conditions

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female
Non-smoker
18-55 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 or vital sign abnormalities
Any abnormal laboratory test
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
Treatment AAlso: cyclobenzaprine HClTNX-102 2.4 mg - 1 gelcap once under fasting conditions.	Drug	Treatment A
Treatment BAlso: cyclobenzaprine HClCyclobenzaprine 5 mg, 1 tablet once under fasting conditions	Drug	Treatment B
Treatment CAlso: cyclobenzaprine HClTNX-102 2.4 mg, 1 gelcap once given under fed conditions.	Drug	Treatment C

Primary outcome

Mean Plasma Concentration (AUC) of Cyclobenzaprine
Time frame: 0 to 96 hours
Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.
Incidences of Adverse Events
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)
Every adverse events occurring during the study period will be reported.

Results and safety

Results posted to the registry on 2 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A First, Then B, Then C	5	4
Treatment A First, Then C, Then B	5	5
Treatment B First, Then A, Then C	5	5
Treatment B First, Then C, Then A	5	5
Treatment C First, Then A, Then B	5	5
Treatment C First, Then B, Then A	5	5

Primary outcome: Mean Plasma Concentration (AUC) of Cyclobenzaprine

Time frame: 0 to 96 hours. Mean (Full Range). Unit: pg.hr/mL

Measure	Treatment A n = 30	Treatment B n = 30	Treatment C n = 30
Value	47,074.19 (30288.11 to 63860.27)	94,874.26 (60588.45 to 129160.07)	50,263.16 (30725.75 to 69800.57)

Primary outcome: Incidences of Adverse Events

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). Count of participants. Unit: Participants

Measure	Treatment A n = 30	Treatment B n = 30	Treatment C n = 30
Subjects with Treatment-Emergent Adverse Events	14	15	10
Subjects with Serious Adverse Events	0	0	0
Subjects discontinued due to adverse event	0	0	0

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 30 (0%)	14 of 30 (46.7%)	0 of 30
Treatment B	0 of 30 (0%)	15 of 30 (50%)	0 of 30
Treatment C	0 of 30 (0%)	10 of 30 (33.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
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

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

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 Treatment A, Treatment B and Treatment C in people with Healthy, 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 5 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 11 Sep 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 2 Nov 2018). 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?

On the ClinicalTrials.gov record for NCT01490788.

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 Sep 2019.