Actively Recruiting
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-03-05
54
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with solid tumors have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation. ASP3082 is thought to replace some of the abnormal proteins made from the faulty KRAS gene. If other medicines are given at the same time as ASP3082, they may affect how the body processes ASP3082. In this study, fluconazole, itraconazole and carbamazepine are given with ASP3082 in healthy adults. The main aims are to check if fluconazole, itraconazole and carbamazepine affect how the body processes ASP3082. These medicines may affect how the body processes ASP3082 when they are taken at the same time. This study will have 3 groups of adults. One group will be given fluconazole and ASP3082, the second group will be given carbamazepine and ASP3082, and the third group will be given itraconazole and ASP3082. ASP3082 will be given to people slowly through a tube into the vein (infusion). Fluconazole and carbamazepine will be given as a tablet and itraconazole will be given as a liquid by mouth. People will be given study treatments for about 1 month. They will then return to the clinic about 1 week after they finish study treatment for a final safety check.
CONDITIONS
Official Title
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is healthy with no significant medical conditions based on exams, ECGs, and lab tests at screening or day -1.
- Female participants are not pregnant and are not women of childbearing potential.
- Female participants are not breastfeeding or lactating from screening through 28 days after the last study treatment.
- Female participants must not donate eggs during the study and for 3 months after the last treatment.
- Male participants agree to use contraception with female partners of childbearing potential during and for 3 months after the study.
- Male participants agree to abstain or use condoms with pregnant partners during and for 3 months after the study.
- Male participants must not donate sperm during and for 3 months after the study.
- Participants agree not to join another interventional study during this study.
- Participants have a BMI between 18.0 and 32.0 kg/m² and weigh at least 50 kg at screening.
You will not qualify if you...
- Positive for HLA-B15:02 or HLA-A31:01 (only for Group 2).
- Pregnant within 6 months prior to screening.
- History or evidence of significant heart, stomach, hormone, blood, liver, immune, metabolic, kidney, lung, nerve, skin, mental, or other major disease.
- History of cancer within 2 years before screening (except certain skin cancers and cured cancers with low recurrence risk).
- Major surgery within 90 days before screening or planned surgery during the study or within 28 days after last dose.
- Fever or symptomatic infections (viral, bacterial, fungal) within 28 days before day -1.
- Drug or alcohol abuse within 2 years before screening.
- History of unexplained fainting, serious heart problems, or family history of long QT syndrome.
- Use of any prescribed or nonprescribed drugs (except occasional acetaminophen, topical skin products, or hormone therapy) within 28 days before day -1.
- Use of metabolism inducers like barbiturates or rifampin within 28 days before day -1.
- COVID-19 vaccine within 14 days before day -1 or planned before study end.
- Use of investigational therapy within 28 days or 5 half-lives prior to screening.
- Liver test results or creatinine levels outside normal limits on day -1.
- Abnormal heart rate, blood pressure, or QT interval on day -1.
- Positive tests for alcohol, drugs of abuse, cannabinoids, hepatitis viruses, HIV, or COVID-19.
- Known hypersensitivity to ASP3082 or its components.
- History of heavy smoking, alcohol use, or drug abuse within specified recent periods.
- Recent significant blood loss, blood donation, or transfusion.
- Previous exposure to ASP3082.
- Employment with study sponsor, CROs, or clinical unit.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Parexel
Baltimore, Maryland, United States, 21225
Actively Recruiting
Research Team
A
Astellas Pharma Global Development Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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