Icalcaprant for Healthy Subjects

(528 Asian PK Trial)

This trial aims to assess how the body processes, reacts to, and tolerates a new drug called icalcaprant. The study focuses on healthy Japanese and Han Chinese individuals to ensure the treatment's safety for these populations. Participants will take a single oral dose of icalcaprant and undergo monitoring for 30 days. Eligibility may include those who are healthy, follow a traditional Japanese or Chinese lifestyle, and have a BMI (a measure of body fat based on height and weight) between 18 and 32. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's likely that you should not be on any regular medications. Please check with the trial organizers for specific guidance.

Research has shown that icalcaprant, the drug tested in this trial, is generally well-tolerated. Studies have examined its safety in various groups, including individuals with bipolar disorder, and found that most can take the treatment without major problems.

Icalcaprant is unique because it offers a new approach by potentially targeting specific pathways that current treatments for related conditions might not address. While many existing options focus on broad mechanisms, Icalcaprant is designed to provide targeted action, which could lead to more effective and faster results. Researchers are excited about its specific action and the possibility of improved outcomes, particularly for different ethnic groups, which could lead to personalized treatment strategies.

This trial will study Icalcaprant in healthy subjects. Studies have shown that Icalcaprant can reduce symptoms in people with bipolar depression. In one study, participants with bipolar disorder experienced improvement in their depression when taking Icalcaprant. Additionally, animal research suggests that Icalcaprant might alleviate withdrawal symptoms from opioids. It blocks certain brain areas involved in mood and reward, which could make it useful for treating mood disorders and addiction. While more research is needed, these findings provide early signs of its potential benefits.¹⁴⁶⁷⁸