A study of TRV045 to test its effects on brain cell electrical activity in healthy adult men for epilepsy treatment development

What is this study about?

This study is looking at a new medicine called TRV045 being developed as a possible treatment for epilepsy. Epilepsy is a condition that affects the brain and causes repeated seizures, which are sudden bursts of electrical activity in the brain that can affect how a person feels, moves, or behaves. In this study, TRV045 will be tested in healthy men who do not have epilepsy to see how the medicine works in the body before it is tested in people with the condition. Some participants will receive TRV045 in capsule form, while others will receive placebo.

The purpose of this study is to see how TRV045 affects the ability of brain cells to respond to electrical signals, which is called cortical excitability. The study will also look at how safe the medicine is, how well it is tolerated, and how the body absorbs and removes it. This is a phase one study, which means it is one of the first times the medicine is being tested in people.

The study is designed as a cross-over trial, which means that participants will receive both TRV045 and placebo at different times during the study, allowing researchers to compare the effects. The medicine will be given multiple times over a period of up to four days. During the study, researchers will measure changes in how the brain responds to magnetic stimulation, which helps them understand how the medicine affects brain activity. The study is randomized and double-blind, meaning that neither the participants nor the researchers will know who is receiving the active medicine or placebo at any given time.

1 Initial consent and enrollment

At the beginning of the study, you will be asked to sign an informed consent form before any study procedures begin.

This consent confirms your agreement to participate and your understanding of what the study involves.

2 Screening and eligibility confirmation

Your eligibility to participate will be confirmed based on specific criteria.

Your body mass index and body weight will be measured to ensure they fall within the required range.

You must be a male between 18 and 55 years of age to participate.

If you are sexually active with a female partner who can become pregnant, you will need to agree to use condoms throughout the study and for 90 days after receiving the last dose of the study medication. Your partner will also need to use a highly effective birth control method.

You will need to agree not to donate sperm from the screening period through 90 days after receiving the last dose of the study medication.

3 Treatment period with crossover design

This study uses a crossover design, which means you will receive two different treatments during two separate periods.

You will be randomly assigned to receive either TRV045 or a placebo in the first treatment period. A placebo is an inactive substance that looks like the real medication but contains no active drug.

In the second treatment period, you will receive the opposite treatment from what you received in the first period.

The study is double-blind, meaning neither you nor the study staff will know which treatment you are receiving at any given time.

You will take the study medication in the form of hard capsules by mouth.

The medication will be given in multiple doses during each treatment period.

4 Brain activity measurements

During the study, measurements will be taken to assess how the study medication affects the electrical activity in your brain, specifically cortical excitability.

Cortical excitability refers to how easily brain cells respond to electrical stimulation.

The primary measurement will be the Motor Evoked Potential, which measures the electrical response of your brain and muscles to stimulation. This will be recorded as changes from your baseline measurements.

5 Safety and tolerability monitoring

Throughout the study, your safety will be monitored continuously.

The study will evaluate how well you tolerate the medication and track any side effects or reactions you may experience.

Various assessments will be conducted to monitor your overall health during the study.

6 Study completion and follow-up

After completing both treatment periods, you will continue to be monitored for safety.

You must continue to follow the contraception requirements for 90 days after receiving the last dose of study medication.

The study will assess how the medication is absorbed and eliminated from your body.

Who Can Join the Study?

You must sign a consent form before any study procedures begin
You must be male and between 18 and 55 years old
Your Body Mass Index (a measure of body fat based on height and weight) must be between 18.0 and 32.0, and you must weigh at least 50 kilograms
If you are 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 medicine
Your female partner must also be willing to use a highly effective birth control method, such as an intrauterine device, diaphragm with spermicide, birth control pills, contraceptive injection, implant under the skin, or tubal ligation (having tubes tied)
You must agree not to donate sperm from the start of the study until 90 days after receiving the last dose of the study medicine
You must be able to communicate effectively in Dutch with the study staff and be willing to follow all study requirements

Who Cannot Join the Study?

Women cannot participate in this study, as only male participants are being enrolled
Children and teenagers cannot participate, as only adults are allowed in this study
Individuals who do not meet the healthy volunteer requirements cannot participate, meaning you must be in good general health without significant medical conditions

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre for Human Drug Research	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	06.02.2023

Trial locations

Investigated drugs:

TRV045

TRV045 is an investigational medication being tested in this study. The purpose of this trial is to see how this medication affects the way brain cells respond to electrical stimulation. Participants will receive TRV045 to help researchers understand its effects on brain cell activity in healthy adults.

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 determine if the effects seen in the study are actually caused by TRV045 or occur naturally without treatment.

Investigated diseases:

Epilepsy

Epilepsy – Epilepsy is a neurological disorder characterized by recurring seizures that occur due to abnormal electrical activity in the brain. These seizures can vary widely in their presentation, from brief lapses in attention or muscle jerks to severe and prolonged convulsions. The condition affects the normal functioning of nerve cells in the brain, causing them to send out incorrect signals. Seizures may be triggered by various factors or occur without any identifiable cause. The frequency and intensity of seizures can differ greatly from person to person. Between seizures, brain function typically returns to normal in most individuals.

Trial ID:

2022-502638-17-00

Protocol code:

CP045-1004

Trial Phase:

Human Pharmacology (Phase I) – Other

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A study of TRV045 to test its effects on brain cell electrical activity in healthy adult men for epilepsy treatment development

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