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A study testing TRV045 for pain relief in healthy adults to understand its effects on nerve pain from diabetic peripheral neuropathy

Investigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy, which is a type of nerve pain that can occur in people with diabetes when high blood sugar levels damage nerves, particularly in the feet and legs. The study will test a new medicine called TRV045 and compare it with placebo to see how well it works in relieving pain. Neuropathic pain is often described as burning, shooting, or stabbing sensations that result from nerve damage rather than injury to the tissue itself.

The purpose of this study is to evaluate how well TRV045 works in reducing pain by using special pain testing methods, including a model that creates temporary mild inflammation on the skin using ultraviolet light. The study is designed as a four-way cross-over trial, which means that participants will receive different treatments in different periods, allowing researchers to compare the effects of the medicine against placebo in the same individuals. This approach helps to better understand whether the medicine provides pain relief.

During the study, healthy adult volunteers between 18 and 55 years of age will take part in testing sessions where they will receive either TRV045 capsules or placebo at different times. The medicine will be given by mouth, with a maximum daily amount of 300 milligrams and a total maximum amount of 400 milligrams over the treatment period. Researchers will measure pain responses using various testing methods and will also monitor the safety of the medicine by checking for any unwanted effects. The study will also measure how the body processes the medicine by taking blood samples to see how much of the drug is present in the bloodstream at different times.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial study period preparation
Your participation will involve a four-way cross-over study design. This means you will receive four different treatments in separate periods, with each treatment given on different occasions.
The study will test TRV045, which is an experimental medication being evaluated for its ability to relieve pain, as well as a placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredients.
Each treatment will be given as a hard capsule that you will take by mouth.
Step 2
Treatment periods
You will go through four separate treatment periods. In each period, you will receive either TRV045 or placebo.
The order in which you receive these treatments will be randomly assigned, and neither you nor the study staff will know which treatment you are receiving during each period. This is called a double-blind approach.
There will be time between each treatment period to allow your body to clear the previous medication before starting the next one. This is known as a washout period.
Step 3
Pain assessment procedures
During the study, your response to pain will be measured using a method called PainCart.
This will include a procedure involving UVB burn, which creates a controlled area of mild skin inflammation similar to a sunburn. This temporary inflammation allows the study team to measure how well the medication relieves pain.
Various measurements will be taken to assess how your body responds to pain stimuli in the affected area.
Step 4
Blood sample collection
Blood samples will be collected during the study to measure the levels of the study medication in your bloodstream.
These measurements, called pharmacokinetic endpoints, help determine how your body absorbs, distributes, and eliminates the medication.
Step 5
Safety monitoring
Throughout the study, your health and any side effects will be closely monitored.
This monitoring is part of the safety and tolerability endpoints, which track how well you tolerate the medication and whether any adverse effects occur.
Step 6
Contraception requirements during study
If you are a female capable of becoming pregnant, you must use a highly effective method of contraception throughout the study and for 180 days after receiving the last dose of study medication.
If you are a male who is sexually active with a female partner capable of becoming pregnant, you must use condoms and your partner must use a highly effective method of contraception throughout the study and for 90 days after receiving the last dose of study medication.
If you are male, you must not donate sperm during the study and for 90 days after receiving the last dose of study medication.

Who can join the trial?

6 criteria

You must be between 18 and 55 years old
Your body mass index (a measure that uses your height and weight to determine if you are in a healthy weight range) must be between 18.0 and 32.0
Your body weight must be at least 50 kilograms (about 110 pounds)
If you are a woman who can become pregnant, you must agree to use a highly effective birth control method such as surgical sterilization (for example, having your tubes tied), or any combination of two barrier methods (such as male condom with diaphragm, sponge, cervical cap, or intrauterine device, or hormonal birth control) from the start of the study until 180 days after receiving the last dose of the study medication
If you are a man who is sexually active with a female partner who can become pregnant, you must agree to use condoms from the start of the study until 90 days after receiving the last dose of the study medication, and your partner must also use a highly effective birth control method during this time
If you are a man, you must agree not to donate sperm from the start of the study until 90 days after receiving the last dose of the study medication

Who cannot join the trial?

3 criteria

The study does not list specific reasons why you cannot participate
Please note that general safety requirements and medical history checks will still apply during the screening process
Your doctor will review your overall health condition to determine if this study is appropriate for you

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Investigated drugs

TRV045
is an investigational pain relief medication being studied in this trial. It is being tested to see how well it works at reducing pain in healthy adults using a special pain testing system that includes an inflammatory model created by UVB light exposure on the skin.
Placebo
is an inactive substance that looks like the real medication but contains no active ingredients. It is used as a comparison to help researchers understand if TRV045 actually works better than no treatment at all.

TRV045

What is already known about the treatment

TRV045 – TRV045 is an experimental pain medication currently being studied in early-stage clinical trials (Phase I) to test its effectiveness in relieving pain. It is being developed specifically to treat nerve pain (neuropathic pain) caused by diabetic peripheral neuropathy, a condition where diabetes damages nerves in the hands and feet. The medication works by targeting specific pain pathways at the molecular level, though its exact mechanism is still being investigated through controlled studies that compare it against placebo in healthy volunteers. Researchers are testing how well it reduces pain responses using specialized pain measurement tools, including models that create temporary inflammation to assess the drug's pain-relieving properties.

Investigated diseases

Diabetic Peripheral Neuropathy – Diabetic peripheral neuropathy is a type of nerve damage that occurs in people with diabetes. High blood sugar levels over time can injure nerve fibers throughout the body, most often affecting nerves in the legs and feet. The condition typically begins with tingling, burning, or numbness in the toes that gradually spreads upward. As the disease progresses, affected individuals may experience sharp pains, increased sensitivity to touch, or loss of sensation in the affected areas. The nerve damage can also lead to muscle weakness and loss of reflexes in the feet and ankles. This condition develops gradually and worsens over time if blood sugar levels remain poorly controlled.