Vimseltinib for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the new drug Vimseltinib affects certain proteins involved in drug metabolism when taken with rosuvastatin, a common cholesterol medication. Researchers primarily assess the safety and tolerability of this combination in healthy men. Participants should be healthy and able to follow the study requirements.
As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I need to stop my current medications to join the trial?
The trial information does not specify if 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 Vimseltinib is likely to be safe for humans?
Research has shown that over 250 patients have tested vimseltinib in various clinical trials. These studies indicate that vimseltinib is generally well-tolerated. One study found it effective and safe, improving patients' health and quality of life. This suggests that vimseltinib is unlikely to cause serious side effects. However, as this is a Phase 1 trial, it marks one of the initial stages of testing the drug in humans. While early results are promising, further research is necessary to fully understand its safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about vimseltinib because it offers a novel approach to treatment by targeting specific pathways that current medications might not address. Unlike the standard of care, which includes treatments like statins (e.g., rosuvastatin) that primarily lower cholesterol by inhibiting cholesterol synthesis, vimseltinib potentially interacts with different biological targets, offering a complementary mechanism. This could mean more effective management of conditions that require cholesterol-lowering, by working alongside existing therapies for a potentially enhanced effect.
What evidence suggests that Vimseltinib might be an effective treatment for breast cancer resistance protein and organic-anion-transporting polypeptide activity?
Research has shown that vimseltinib may help treat certain health issues. In studies with patients who have tenosynovial giant cell tumor (a type of joint tumor), vimseltinib led to noticeable improvements. Patients reported feeling better and experiencing positive changes in their health. These studies also found that vimseltinib helped shrink the tumors. However, some patients experienced side effects, such as higher levels of certain blood enzymes. Overall, evidence suggests vimseltinib could be effective for some tumor-related conditions.
In this trial, healthy subjects will receive a combination of rosuvastatin and vimseltinib to evaluate the effects and safety of vimseltinib when administered with rosuvastatin.25678Who Is on the Research Team?
Clinical Team
Principal Investigator
Deciphera Pharmaceuticals, LLC
Are You a Good Fit for This Trial?
This trial is for healthy male participants with a BMI between 18 to 32 kg/m^2. They must be in good general health and have adequate organ function, as well as acceptable blood and urine test results, all determined by the study's Principal Investigator.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rosuvastatin as a single dose on Day 1 and Day 8, and Vimseltinib daily from Days 5 through 8
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vimseltinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Deciphera Pharmaceuticals, LLC
Lead Sponsor