Ended Human Pharmacology (Phase I)- Other Epilepsy

A study investigating the safety, tolerability, absorption, excretion and effects of a new drug for the treatment of epilepsy.

EU CTIS ID: 2022-502638-17-00

What this study is testing

To evaluate how TRV045 affects the ability of the brain cells to conduct electrical stimulation (cortical excitability) in healthy male adults.

  • Human Pharmacology (Phase I)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Signed informed consent prior to any study-mandated procedure.
  • Male subjects between ≥ 18 and ≤ 55 years of age.
  • Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
  • Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from screening through 90 days after administration of the last dose of IMP, and their partners must be willing to use a highly effective method of contraception (e.g., intrauterine device [IUD], diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant, or tubal ligation).
  • Subjects must agree to not donate sperm from screening through 90 days after administration of the last dose of IMP.
  • Subjects must be able to communicate effectively (in Dutch) with the study personnel and must be willing to comply with the requirements of the study.

You likely can't join if

  • Evidence of any acute (at screening or prior to first dose) or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, VSs [systolic and diastolic BP, PR, body temperature] and 12-lead ECG). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
  • History or presence of conditions which, in the judgment of the investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  • History or presence of any condition that, in the judgment of the investigator, might increase the risk (or worsening) of infection, including but not limited to an active viral or bacterial infection, respiratory condition (e.g., asthma, chronic obstructive pulmonary disease, chronic sinusitis, or bronchitis), recent surgery or major trauma (within 12 weeks of screening), or surgery planned during the study period.
  • History or presence of conditions which, in the judgment of the investigator, might increase the risk of performing TMS, including but not limited to epilepsy or febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device.
  • Any condition that could interfere with the quality of or ability to perform TMS, such as an abnormal sleeping pattern (e.g., working night shifts), dreadlocks or hairpieces that cannot be removed or a rMT of more than 75% of the maximum stimulator output as measured using TMS-EMG during screening.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.