Fluconazole, Carbamazepine, and Itraconazole for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess how different medications affect the body's processing of a new treatment called ASP3082, an experimental therapy. ASP3082 targets a gene change that can lead to cancer. Researchers seek to determine if combining it with other drugs, such as fluconazole, carbamazepine, and itraconazole, makes a difference. Healthy adults without significant health issues or recent drug use may qualify for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that ASP3082 is generally safe. Researchers tested it on 111 patients with specific cancer mutations and found that even at higher doses, it was well-tolerated, with no severe side effects reported.
Fluconazole is usually safe, but some studies suggest it may not always benefit certain patients. Carbamazepine has been safely used with other drugs without losing effectiveness, though possible toxicity should be noted. Itraconazole can cause side effects like liver problems in about 7% of patients, but many do not experience these issues.
Overall, researchers are combining these treatments with ASP3082 to evaluate their combined effects. Each treatment has been used in patients before, providing some understanding of their safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ASP3082 because it offers a novel approach by being combined with different drugs like fluconazole, carbamazepine, and itraconazole. Most treatments for conditions requiring these drugs focus on a singular drug action, but ASP3082 is designed to work synergistically with these existing medications, potentially enhancing their effectiveness. This combination strategy could lead to more efficient and faster results due to ASP3082's unique mechanism of action, making it a promising candidate compared to the standard treatments.
What evidence suggests that this trial's treatments could be effective?
Research has shown that ASP3082 is a promising treatment for tumors with the KRAS G12D mutation. In studies involving patients with advanced solid tumors, ASP3082 controlled the disease in 84.6% of cases and reduced tumor size in 23.1% of cases. Many patients experienced tumor shrinkage or halted growth. ASP3082 targets and breaks down the faulty proteins caused by the KRAS G12D mutation, potentially stopping tumor growth. In this trial, researchers are examining how ASP3082 interacts with other drugs like fluconazole, itraconazole, and carbamazepine to understand their effects on its processing in the body. Participants will be divided into groups to receive ASP3082 with one of these drugs, although these drugs are not being tested as treatments for the mutation.26789
Who Is on the Research Team?
Medical Director
Principal Investigator
Astellas Pharma Inc
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ASP3082 with either fluconazole, carbamazepine, or itraconazole for about 1 month
Follow-up
Participants return to the clinic for a final safety check after completing the treatment phase
What Are the Treatments Tested in This Trial?
Interventions
- ASP3082
- Carbamazepine
- Fluconazole
- Itraconazole
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants receive ASP3082 on Days 1 and 15 and itraconazole on Days 8 to 28.
Participants receive ASP3082 on Days 1 and 22 and carbamazepine on Days 8 to 28.
Participants receive ASP3082 on Days 1 and 15 and fluconazole on Days 8 to 28.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available
Citations
A study to learn how fluconazole, carbamazepine and ...
In this study, fluconazole, itraconazole and carbamazepine are given with ASP3082 in healthy adults. The main aims are to check if fluconazole, itraconazole and ...
Impact of carbamazepine on SMARCA4 (BRG1) expression in ...
Our study finds that Carbamazepine affects SMARCA4 levels and that this effect is different depending on the KRAS mutation status.
Astellas 3082-CL-0301: Phase 3 study testing safety and ...
Purpose of study: The purpose of the study is to see if the study drug ASP3082 is a safe and effective treatment for patients with metastatic pancreatic ductal ...
Carbamazepine - Drug Targets, Indications, Patents
The efficacy and safety of Carbamazepine in controlling seizures and mood swings associated with bipolar disorder is well-established. Furthermore, its ...
ASP3082 for Cancer · Recruiting Participants for Phase ...
These findings suggest that ASP3082 may be effective for tumors with the KRAS G12D mutation. In this trial, researchers are testing ASP3082 in various treatment ...
NCT07395024 | A Study to Learn How Fluconazole, ...
In this study, fluconazole, itraconazole and carbamazepine are given with ASP3082 in healthy adults. The main aims are to check if fluconazole, itraconazole and ...
setidegrasib (ASP3082) / Astellas
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults (clinicaltrials.gov) - P1 | N=54 ...
Drug Interaction Study in Healthy Subjects
The study lasted for 7 days, and the results suggest that cimetidine can be safely administered alongside carbamazepine without altering its effectiveness.
A study of ASP3082 in adults with advanced solid tumors
The key reasons people cannot take part are if they have symptomatic or untreated cancers in the brain or nervous system, their cancer has spread to the thin ...
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