Itraconazole + Rifampin 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 experimental drug INCB161734 behaves in the body when combined with common medications such as itraconazole, rifampin, and acid reducers. Researchers seek to determine how these combinations affect the drug's absorption and processing. The trial is specifically for healthy individuals with no recent history of serious illnesses who can take oral medications. Those who have been healthy for the past six months and can commit to following study rules might be a good fit. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.
Do I have to stop taking my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves healthy participants and tests drug interactions, it's possible that some medications might need to be paused. Please consult with the trial coordinators for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that INCB161734, a new drug under testing, is generally well-tolerated when used alone or with other cancer treatments. So far, research has not found clear evidence of serious side effects. For example, previous participants in studies experienced no noticeable harmful effects, suggesting the treatment may be safe.
Famotidine, used in one of the trial groups, is a well-known medicine for stomach issues and is considered safe for most people. Similarly, esomeprazole is commonly used to reduce stomach acid and is known to be safe. Itraconazole and rifampin, other drugs used in the study, are also recognized for their safety when used correctly.
This trial is in its early stages, focusing mainly on safety and drug tolerance. This suggests that INCB161734 and its combinations with the other drugs are likely safe, but further testing will help confirm this.12345Why are researchers excited about this trial's treatments?
Researchers are excited about INCB161734 because it combines with different drugs (itraconazole, rifampin, famotidine, and esomeprazole) to potentially enhance its effectiveness and safety in healthy subjects. Unlike many treatments that might focus on a single pathway, this drug is being explored in combination with these other agents to see if it can improve absorption, reduce side effects, or offer other benefits. This approach could offer a fresh perspective on managing conditions that involve these combinations, potentially leading to more personalized and effective treatment options.
What evidence suggests that this trial's treatments could be effective?
Research has shown that INCB161734 has promising early results, particularly for cancers with specific genetic changes. In studies, INCB161734 demonstrated early signs of efficacy in patients with pancreatic and colorectal cancers. In this trial, participants in different cohorts will receive INCB161734 combined with other drugs. For example, when used with itraconazole, the level of INCB161734 in the body increased significantly, potentially enhancing its effectiveness. Early findings suggest this treatment could be effective and safe for further research. However, more information is needed to fully confirm these benefits.36789
Who Is on the Research Team?
Incyte Medical Monitor
Principal Investigator
Incyte Corporation
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-55 with a BMI of 18.0 to 32.0 kg/m2 who can swallow pills and agree to follow study rules, including avoiding pregnancy or fathering children during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive INCB161734 with itraconazole, rifampin, esomeprazole, or famotidine to assess pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- INCB161734
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School