Itraconazole for Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study the interaction between itraconazole (an antifungal medication) and LY4395089 (a new potential drug) in healthy individuals. Researchers will conduct blood tests to determine how the body processes these drugs and their effects. Participants will stay at a clinical research unit for about two weeks. The trial seeks healthy individuals who can commit to the study duration and have no major health issues or history of conditions like heart disease or liver problems. 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 a new potential drug.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LY4395089 has been tested in people with Crohn's Disease and Ulcerative Colitis. These studies found no increased risk of infections or heart problems, suggesting it might be safe for humans.
Safety data from many studies involving over 2,000 people indicate that itraconazole is generally well-tolerated. Most participants did not experience serious side effects, although rare reports of liver issues occurred.
Limited specific data exist on the combined use of itraconazole and LY4395089. However, studies on their interaction have not revealed major safety concerns.
This study is in its early phase, focusing primarily on the safety of these treatments when given together to healthy people. While early-phase studies mainly assess safety, they suggest the treatment is likely to be well-tolerated.12345Why are researchers excited about this trial's treatments?
Itraconazole and LY4395089 are unique because they explore new possibilities for treatment. Most antifungal treatments focus solely on inhibiting fungal growth, but Itraconazole, traditionally used to treat fungal infections, is being investigated here in a new context. Researchers are particularly intrigued by LY4395089, as it represents a novel compound with potential new mechanisms of action. The combination of LY4395089 and Itraconazole could offer enhanced effectiveness, possibly improving outcomes by leveraging the strengths of both compounds together.
What evidence suggests that this trial's treatments could be effective?
Research has shown that LY4395089 can help reduce gut inflammation, which is important for managing conditions like Crohn's disease. One study found that 44% of people taking LY4395089 achieved the main treatment goal, compared to 33% who took a placebo. This suggests that LY4395089 may benefit gut health. In this trial, some participants will receive LY4395089 alone.
Itraconazole effectively treats fungal infections. Studies indicate that itraconazole significantly reduces these infections compared to other treatments. It is often used for serious fungal conditions and has a strong track record in preventing them. Other participants in this trial will receive itraconazole alone.
The trial is studying the combination of LY4395089 and itraconazole because each medicine works well in its own area. Together, they might provide even better results by addressing different health issues simultaneously. Participants in this trial may receive this combination treatment.15678Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for healthy adults who do not have any significant medical conditions. Participants should not be taking medications or have health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LY4395089 and Itraconazole orally to study pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Itraconazole
- LY4395089
Trial Overview
The study tests how itraconazole (an antifungal medicine) affects the way the body processes another drug, LY4395089. Healthy volunteers will stay at a clinic and undergo blood tests over about two weeks.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
LY4395089 and Itraconazole administered orally
LY4395089 administered orally
Itraconazole administered orally
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
Trough concentration of itraconazole and its relationship with ...
The efficacy outcomes were rate of successful treatment, rate of prophylaxis failure and invasive fungal infection (IFI)-related mortality. The safety outcomes ...
Effect of Different Itraconazole Dosing Regimens in Adult ...
This randomized clinical trial compares cure rates, treatment durations, safety profiles, and relapse rates of itraconazole, 100, 200, ...
Comparing the Efficacy of Oral Fluconazole Versus ...
Participants in this arm will receive oral itraconazole 200 mg once daily for 4 weeks. Treatment will be administered at the Dermatology ...
Itraconazole to Prevent Fungal Infections in Chronic ...
The elimination half-life of itraconazole in healthy adult volunteers is approximately 20 hours after a single dose and 30 hours after multiple doses.
Itraconazole + PF-07258669 for Healthy Adults
The study tests how itraconazole and food affect the body's processing of PF-07258669, aimed at treating unintended weight loss in older adults. It involves ...
A Study of the Effects of Itraconazole on LY4395089 in ...
A Study of the Effects of Itraconazole on LY4395089 in Healthy Participants. ClinicalTrials.gov ID NCT07592572. Sponsor Eli Lilly and Company.
The Impact of Itraconazole, a Strong CYP3A4 Inhibitor, on ...
This study assessed the pharmacokinetics and safety of camlipixant with itraconazole, a strong CYP3A4 inhibitor, in healthy participants.
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sciencedirect.com
sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/itraconazoleItraconazole - an overview
Data on the safety of itraconazole have been collected in an open, randomized, multicenter study in 277 adults with cancer and neutropenia · Itraconazole (400 mg ...
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