Varegacestat for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the body processes a single dose of varegacestat, a new drug under study in healthy male volunteers. Researchers are examining how the drug moves through the body and how it breaks down. Healthy males who have not participated in another drug trial recently and have no major health issues are suitable candidates for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that varegacestat is likely to be safe for humans?
Previous studies have tested varegacestat in healthy volunteers to assess its safety. One study examined the drug's interaction with itraconazole, a common antifungal medication, and identified some side effects after administration. Such findings are typical in early research and help determine the drug's tolerability.
Another study investigated the effects of varegacestat on individuals with liver problems and healthy participants. Although specific results are not provided, monitoring liver effects is a standard part of early testing to ensure safety.
Varegacestat belongs to a group of drugs called GSIs (gamma-secretase inhibitors), which have an established safety profile. Researchers have some knowledge of the usual side effects and how to manage them.
As this trial is in the first phase, it represents the initial step in testing the drug in humans, focusing primarily on identifying any side effects. This stage typically involves fewer participants, with an emphasis on safety rather than effectiveness.12345Why do researchers think this study treatment might be promising?
Varegacestat is unique because it targets the gamma-secretase enzyme, a mechanism not typically exploited by current treatments. Most existing therapies focus on different pathways or symptoms, but varegacestat's novel approach has the potential to address underlying causes more directly. Researchers are excited about this treatment because it represents a new way to tackle the condition, potentially offering more effective results or fewer side effects compared to traditional options.
What evidence suggests that varegacestat could be effective?
Research has shown that varegacestat, an oral medication, has potential in treating certain conditions. In a study on desmoid tumors, varegacestat reduced tumor size in 71.4% of patients, indicating its ability to manage tumors by affecting specific cell processes. Although this trial focuses on healthy volunteers, the mechanism of varegacestat suggests it might benefit other conditions as well. Further studies will clarify its effectiveness in various medical situations.12346
Are You a Good Fit for This Trial?
This trial is for healthy male participants who meet specific health criteria. The exact inclusion and exclusion details are not provided, but typically these would involve certain age ranges, no current medications or health conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of [14C]varegacestat following an overnight fast
Follow-up
Participants are monitored for absorption, metabolism, excretion, and mass balance of varegacestat
What Are the Treatments Tested in This Trial?
Interventions
- Varegacestat
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immunome, Inc.
Lead Sponsor