Active not recruitingPHASE1INTERVENTIONAL

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants

This study is testing a new way to deliver a medicine called TNX-102 SL, which is already approved in the US for a condition called fibromyalgia. Fibromyalgia causes widespread pain, tiredness, and sleep problems. This drug is given as a tablet that dissolves under the tongue. Researchers want to see how safe it is and how it's absorbed into the body in both younger and older people. By comparing these two age groups, they hope to understand if older adults might need a different dose or if the drug works differently for them. This is a very early-stage study, meaning it’s a first step in understanding the drug better.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Tonix Pharmaceuticals, Inc.

Enrolment target

Start

09 Dec 2025

Estimated completion

10 Feb 2026

Pharmakokinetic Open Label Phase 1

What is this study about?

This study is about understanding how a medicine called TNX-102 SL works in the body. This drug is designed to help people with fibromyalgia, a condition that causes widespread pain, fatigue, and difficulty sleeping. In the United States, this particular drug has already been approved for use, where it's known by the brand name TONMYA.

The researchers want to compare how the drug is handled by the bodies of younger adults (aged 18 to 45) versus older adults (aged 65 and over). They are particularly interested in its 'pharmacokinetics' — a medical term that simply means how the body absorbs, distributes, breaks down, and gets rid of a drug. They'll also be checking for safety in both groups.

By comparing these groups, scientists can learn if age affects how the drug works. This information is really important because it helps doctors decide the right dose for different patients and understand if any side effects might be more likely in older people. This study is an important step in making sure new medicines are safe and effective for everyone.

Key takeaways

Tests a sublingual (under-the-tongue) drug for fibromyalgia.
Compares drug effects in younger (18-45) and older (65+) adults.
Focuses on safety and how the drug is absorbed by the body.
Early-stage study (Phase 1) — information is for research purposes.
Drug is approved in the US for fibromyalgia, but not in the UK or Canada.

Who may be eligible?

To join this study, participants need to be either a younger adult (between 18 and 45 years old) or an older adult (65 years or older). Both men and women can take part. You'll need to be generally healthy, or if you're an older participant, any long-term health conditions you have must be stable and not likely to cause problems with the study drug.

There are also some physical requirements, like having a healthy body weight. You cannot have certain serious health problems, such as severe heart, kidney, or liver conditions, or some eye conditions like glaucoma, unless the research team agrees they are minor and won't affect the study. You also can't have had any major illness or surgery recently.

For women, if you are past menopause (meaning you haven't had a period for at least 12 months) you may be able to join. If you are still able to have children, specific criteria would need to be met, but the details aren't provided here.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 45 years old, or 65 years or older?
Are you generally healthy, or is any long-term condition you have stable and well-managed?
Do you have a healthy body weight for your height?
Have you had any major surgery or serious illness recently (in the last 4 weeks)? (If yes, you may not be eligible.)
Are you a woman past menopause, or, if not, are you willing to discuss birth control requirements? (Specifics not provided for women of child-bearing potential.)
Do you have severe heart, kidney, liver, or eye conditions like angle-closure glaucoma? (If yes, you may not be eligible.)

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the study drug TNX-102 SL as a tablet that dissolves under your tongue. The study is 'open-label,' meaning both you and the study team will know you are receiving the active drug. As this is a 'Phase 1' study, the main focus is on the safety of the drug and how it moves through your body, so there will be regular checks of your blood and general health. The detailed description of how many visits, tests, and the exact length of the study isn't provided here, but Phase 1 studies typically involve a short period of close monitoring in a clinic or hospital setting.

Potential risks and benefits

Potential benefits of participating include contributing valuable information that could help shape future medical treatments, especially for fibromyalgia, and receiving careful medical monitoring during the study. However, the drug may have side effects, which are not fully known at this early stage. There is always a risk that the drug might not help or could cause unwanted effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Syneos Health Clinique, Inc.
Verified postcode
Québec, Canada

Common questions

What is fibromyalgia?

Fibromyalgia is a long-term condition that causes widespread pain all over the body, along with extreme tiredness and sleep problems.

What is TNX-102 SL?

TNX-102 SL is a medicine that dissolves under the tongue, already approved in the US for treating fibromyalgia. It's brand name there is TONMYA.

What does 'Phase 1' mean for a study?

Phase 1 means it's an early-stage study, usually the first time a new medicine is tested in people. The main goals are to check its safety and how the body handles it.

Why are they studying younger and older people separately?

Researchers want to see if the drug affects younger and older people differently, as age can change how the body processes medicines. This helps find the right dose for everyone.

Is this drug approved in the UK or Canada?

No, this drug is currently only approved in the United States and is not approved for any conditions in Canada. The study helps gather information that might lead to approvals elsewhere in the future.