INCB123667 for Healthy Subjects

This trial aims to understand how food and drugs like itraconazole and rifampin interact with a new oral treatment called INCB123667 in healthy adults. Researchers are testing how the body absorbs and processes the treatment under different conditions, such as with or without food and alongside other medications. Individuals who are generally healthy, have no major medical conditions, and can swallow tablets might be suitable candidates. 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 it.

Yes, you will need to stop taking prescription drugs within 14 days and nonprescription medications within 7 days before the study drug is given, except for occasional standard-dose acetaminophen, ibuprofen, and standard-dose vitamins.

Research has shown that INCB123667, a CDK2 inhibitor, is generally well tolerated. In earlier studies, most participants experienced side effects such as nausea, low red blood cell count (anemia), and low platelet count (thrombocytopenia). However, only 2.4% discontinued the drug due to side effects, and less than 10% required a dose reduction. Taking up to 125 mg daily proved manageable for most.

Specific information on the combination of INCB123667 with itraconazole is limited. Itraconazole, used for other conditions, has known side effects. Combining drugs can sometimes increase risks.

Even less information is available on the combined safety of INCB123667 and rifampin. Rifampin, often used to treat tuberculosis, can be unsafe at higher doses, necessitating caution.

Researchers are excited about INCB123667 because it has the potential to offer a new way to tackle conditions that standard treatments might not fully address. Unlike traditional therapies, which typically involve broad mechanisms of action, INCB123667 is designed to target specific pathways related to the disease. This precision could lead to more effective treatments with fewer side effects. The study also explores how INCB123667 interacts with other drugs, like itraconazole and rifampin, which could provide insights into optimizing treatment regimens.

Research has shown that INCB123667 may help treat advanced solid tumors, such as ovarian cancer, by blocking a protein called CDK2, which aids cell division. Early studies found that patients with ovarian cancer responded well to this treatment. In this trial, participants in different cohorts will receive INCB123667 under various conditions. Some will receive INCB123667 alone, either fasted or fed, while others will receive it with itraconazole, a drug that can alter how other medications work in the body, potentially affecting the effectiveness of INCB123667. Another cohort will receive INCB123667 with rifampin, which accelerates drug breakdown and could also impact how well INCB123667 works. Overall, current evidence suggests that INCB123667 could be beneficial, especially for certain types of cancer.⁶⁷⁸⁹¹⁰