A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07395024
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Setidegrasib — DRUG
    Intravenous (IV) infusion
  • Fluconazole — DRUG
    Oral
  • Carbamazepine — DRUG
    Oral
  • Itraconazole — DRUG
    Oral

Study Details

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.

Key Dates

Start date
Feb 3, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: ASP3082 + Fluconazole
    Participants receive ASP3082 on Days 1 and 15 and fluconazole on Days 8 to 28.
  • Experimental: Group 2: ASP3082 + Carbamazepine
    Participants receive ASP3082 on Days 1 and 22 and carbamazepine on Days 8 to 28.
  • Experimental: Group 3: ASP3082 + Itraconazole
    Participants receive ASP3082 on Days 1 and 15 and itraconazole on Days 8 to 28.

Primary Outcome Measure

Pharmacokinetics (PK) of ASP3082 in plasma: Maximum Concentration (Cmax) in ASP3082 [ Time Frame: Up to 29 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ParexelBaltimoreMaryland21225-

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By research site
Parexel· Baltimore, MD

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