Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A phase I, randomized, double-blind, placebo-controlled, four-way cross-over study to evaluate the analgesic effects of TRV045 in healthy adults

This study is looking at a new potential pain relief medicine called TRV045. It's an early-stage study, meaning it's one of the first times this medicine is being tested in people. The main goal is to understand how TRV045 affects the body and if it's safe and well-tolerated. For this, healthy adult volunteers will receive either TRV045 or a dummy medicine. To see how it works, researchers will use a special light, similar to sunlight, to create a very mild, temporary sunburn on a small area of skin. This allows them to measure how the medicine might change the feeling of pain. This research is important for conditions like nerve pain caused by diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Trevena Inc.

Enrolment target

Start

15 Nov 2022

Acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy

What is this study about?

This research study is about a new medicine called TRV045. It's still very early in its development, which means this study is one of the first times it's being tested in people. The main aim is to find out how TRV045 works in the body, how much of it stays in the body over time, and if it's safe for people to take.

Even though the medicine is being developed to help people with nerve pain (like that caused by diabetes), this early study is actually done with healthy volunteers, not people who already have pain. This is a common and important step in developing new medicines. By testing it in healthy people first, scientists can get a clearer idea of the medicine's basic effects and safety without other health conditions getting in the way.

To understand how the medicine might affect pain, researchers will use a special, safe method. They'll expose a small area of skin to ultraviolet B (UVB) light, which causes a mild, temporary sunburn sensation. This controlled way of creating a small, temporary pain allows them to measure if the medicine changes how people feel pain, without actually needing people to be in pain beforehand.

Key takeaways

This is an early-stage study (Phase I) of a new medicine called TRV045.
It aims to check the safety and how the medicine works in healthy adults.
A small, temporary sunburn will be used to measure pain responses.
You might receive the active medicine or a placebo at different times.
Your involvement helps research for future pain treatments.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or over. This study is open to both men and women.

It's really important that you don't have any major health problems, as the study is looking at how the new medicine works in a healthy person. You would have a health check-up to make sure you're suitable.

Other specific medical criteria would also apply to ensure your safety and the accuracy of the study results. These will be fully explained by the study team.

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 18 years old or older?
Are you generally healthy with no major medical conditions?
Are you willing to follow study procedures, including blood tests and skin exposure to light?
Are you able to attend multiple study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would attend several appointments over a period of time. During these visits, you would receive either the active study medicine (TRV045) or a placebo (a dummy medicine that looks the same but contains no active drug). You'd take both at different times as part of a 'four-way cross-over' design, meaning everyone gets different sequences of the medicine and placebo. Neither you nor the study team would know which you are taking at any given time.

A key part of the study involves having a small area of skin exposed to 'UVB light'. This is like a very controlled, mild sunburn, which helps the researchers understand how the medicine might affect pain. You would also have blood samples taken regularly to see how your body handles the medicine (this is called 'pharmacokinetics') and undergo various safety checks and assessments throughout the study. The total duration of your involvement, including initial screening and follow-up, would be explained in full detail.

Potential risks and benefits

Participating in any study has potential benefits and risks. There's no direct personal health benefit for you from taking part in this specific study, as it's an early-stage trial in healthy volunteers. However, your contribution is vital in advancing medical science, potentially leading to new treatments for people suffering from severe pain conditions. Potential risks include side effects from the study medicine, discomfort from blood tests, or the mild, temporary sunburn experience. All procedures will be fully explained before you agree to take part, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What does 'phase I study' mean?

It means this is one of the first times the medicine is being tested in people, usually healthy volunteers. The main aims are to check safety and how the medicine acts in the body.

Why is a 'placebo' used?

A placebo is a dummy medicine and is used to compare against the real medicine. This helps researchers understand if any effects seen are truly due to the study medicine or something else.

What is the 'UVB pain model'?

It's a way for researchers to safely create a very mild, temporary sunburn on a small area of skin. This allows them to measure how much pain you feel, and whether the study medicine changes that feeling.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know when you're receiving the active medicine or the placebo. This helps make the study results more reliable.

Is TRV045 already available as a medicine?

No, TRV045 is an experimental medicine that is still in development. It's not yet approved for use and is only available through studies like this one.