Itraconazole and Cyclosporine for Drug Interaction Study
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
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.
This trial is in an early research phase, focusing on the safety and metabolism of these drugs. While these drugs are approved for other uses, their combination with danuglipron is still under study to ensure safety.12345Why are researchers excited about this trial's treatments?
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.
What evidence suggests that this trial's treatments could be effective?
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.
Similarly, cyclosporine interacts with other drugs, affecting their efficacy. Participants in another arm of this trial will receive cyclosporine with danuglipron. Danuglipron, the main focus here, has shown promising results in aiding weight loss compared to a placebo. These interactions with itraconazole and cyclosporine can help researchers learn how to use danuglipron more effectively with other treatments.678910Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for healthy adults over 18 years old with a BMI of 16-32 kg/m2 and weight above 50 kg. Participants must be in good health as confirmed by medical history, physical exams, lab tests, blood pressure, pulse rate, and ECG readings.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive danuglipron, cyclosporine, and itraconazole in a fixed sequence to evaluate pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclosporine
- Itraconazole
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University