Vimseltinib for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effects of vimseltinib, a new potential drug, when combined with metformin, a common diabetes medication. Researchers aim to understand how the body processes (pharmacokinetics) these drugs together and assess their safety in healthy men. The trial targets men in good health with a body mass index (BMI) between 18 and 32, who do not have significant health issues or diseases. 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 drug.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves healthy participants and assesses the effect of vimseltinib with metformin, it's possible that you may need to avoid other medications. Please consult with the study team for specific guidance.
Is there any evidence suggesting that vimseltinib is likely to be safe for humans?
Research has shown that vimseltinib is generally safe for people. In a study with 253 patients, vimseltinib proved effective and improved their health and quality of life. These patients did not report any unexpected side effects, suggesting the treatment's safety. While researchers continue to study vimseltinib, it has shown promise in other research, providing benefits without major safety issues.12345
Why do researchers think this study treatment might be promising?
Vimseltinib is unique because it works differently from the typical treatments for conditions like cancer, which often involve chemotherapy or targeted therapies. Unlike these standard options, Vimseltinib is a small molecule inhibitor that specifically targets and blocks the activity of CSF1R, a receptor involved in the growth and survival of certain cancer cells and tumor-associated macrophages. Researchers are excited about Vimseltinib because it has the potential to more precisely disrupt cancer cell processes, potentially leading to fewer side effects and better outcomes for patients. Additionally, its daily oral administration could offer a more convenient and less invasive option compared to traditional intravenous therapies.
What evidence suggests that vimseltinib might be an effective treatment for healthy subjects?
Research has shown that vimseltinib offers promising results for treating tenosynovial giant cell tumor (TGCT), a type of tumor in joint tissue. Studies have found that patients treated with vimseltinib experienced significant tumor response improvements. In one study, patients tolerated vimseltinib well, and it demonstrated strong activity against tumors. Most patients reported meaningful improvements in their symptoms and quality of life. While the current trial involves healthy participants receiving a combination of Metformin and Vimseltinib, earlier findings suggest that vimseltinib could effectively treat TGCT.25678
Who 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 should be in good health as determined by the Principal Investigator and have adequate organ function along with acceptable blood and urine test results.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive metformin as a single dose on Day 1 and Day 6, and vimseltinib daily from Day 3 to Day 6
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