Varegacestat + Itraconazole Interaction Study in Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the interaction between two drugs, varegacestat and itraconazole, in the body. Researchers will first study varegacestat alone and then observe its combination with itraconazole, an antifungal medication. The findings could determine whether taking these drugs together affects their effectiveness or safety. Healthy adults with no significant medical history might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves healthy participants, it's likely that you should not be on any medications that could affect the study results.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that varegacestat, the treatment being tested in this study, has been well-tolerated in earlier trials. Studies have found no major safety concerns so far, indicating that most participants did not experience serious side effects.
As this study is in Phase 1, it primarily focuses on understanding the treatment's safety and how it works in the body. Although this phase involves fewer participants and is in the early stages of testing, it suggests that serious risks are likely rare. Participants should remain aware that this is an early-stage study, so unexpected effects can occur, but current data are reassuring regarding safety.12345Why do researchers think this study treatment might be promising?
Varegacestat is unique because it targets gamma-secretase, an enzyme involved in various cellular processes. Unlike traditional treatments that may not directly target this enzyme, varegacestat potentially offers a novel approach by inhibiting gamma-secretase activity. Researchers are excited about this treatment because it might provide a different mechanism of action compared to current options, potentially leading to more effective outcomes or reduced side effects for conditions where gamma-secretase is implicated.
What evidence suggests that this trial's treatments could be effective?
This trial studies Varegacestat to understand its interaction with other drugs, specifically Itraconazole, in healthy volunteers. Research has shown that Varegacestat targets an enzyme linked to diseases like Alzheimer's, and blocking this enzyme might help slow these diseases. Itraconazole is used in studies to examine its effect on the metabolism of other drugs. The trial aims to understand the interaction between Varegacestat and Itraconazole, which could enhance future treatment plans.
Who Is on the Research Team?
Michelle Valentine
Principal Investigator
Celerion
Are You a Good Fit for This Trial?
This trial is for healthy individuals who can participate in a study to understand how the drug Varegacestat interacts with Itraconazole. Specific eligibility criteria are not provided, but typically participants must be adults without any significant health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Single dose of varegacestat administered with PK evaluated predose and up to 192 hours postdose
Washout
14-day washout period between Period 1 and Period 2
Treatment Period 2
Itraconazole administered once daily for 18 days; varegacestat administered on Day 4 with PK evaluation up to 744 hours postdose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Itraconazole
- Varegacestat
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immunome, Inc.
Lead Sponsor