Itraconazole and Cyclosporine for Drug Interaction Study

This trial aims to understand how the medicine danuglipron interacts in the body when taken with cyclosporine (an immunosuppressant) and itraconazole (an antifungal medication). The research will help determine safe and effective ways to use danuglipron alongside these medications in the future. Participants will take these drugs in different combinations, and researchers will measure their effects on danuglipron levels. Healthy adults without significant medical history and not on other medications might be a good fit for this study. As a Phase 1 trial, this research focuses on understanding how danuglipron works in people, offering participants the opportunity to be among the first to receive this treatment.

The trial requires participants to stop using prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives before the first dose of the study medicine. This means you may need to stop taking your current medications, but it's best to discuss this with the study team for specific guidance.

Research has shown that both cyclosporine and itraconazole have been studied for their safety in humans. Cyclosporine, often used to prevent organ rejection, is generally safe. Most people tolerate it well, though some might experience higher blood pressure or kidney problems, which doctors usually monitor.

Itraconazole treats fungal infections and has also been tested in humans. Studies have found that itraconazole is usually safe when taken as directed. However, it can interact with other medications, highlighting the importance of this study. Some people might experience side effects like nausea or dizziness.

Researchers are excited about these treatments because they explore how itraconazole and cyclosporine interact with danuglipron, potentially enhancing its effects. Itraconazole and cyclosporine are known for their ability to affect drug metabolism and absorption, which could lead to more effective use of danuglipron. Unlike standard treatments that might not leverage these interactions, this approach could offer a more precise and potent therapeutic option. This trial aims to uncover how these combinations might optimize treatment outcomes, offering new insights into personalized medicine.

This trial will study the interactions of danuglipron with itraconazole and cyclosporine. Studies have shown that itraconazole can significantly increase the levels of certain medicines in the blood. For example, one study found it doubled the concentration of another drug. This suggests itraconazole might enhance the effectiveness of some medications by increasing their levels in the body. In this trial, participants in one arm will receive itraconazole along with danuglipron.