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A Study to Learn How ASP3082 is Processed in Healthy Men

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Primary endpoints: details revised at 1 of 17 entries · Study sites: 0 to 1 · Start date changed from estimate of Aug 31, 2026 to Aug 28, 2026 · 2 more Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 17 entries
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 31, 2026 to Aug 28, 2026
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 3 of 7 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Setidegrasib (ASP3082) is being developed for certain cancers. In this study, the researchers want to understand how it is processed by the body in healthy male volunteers. To do this, \[14C\] which is a certain chemical (called a tracer, or radionuclide) has been added to setidegrasib. \[14C\] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. \[14C\] will be picked up by a scanner and will be used to follow setidegrasib through the body. \[14C\]setidegrasib will be given as 1 single injection slowly through a vein (infusion). The men will stay overnight in the clinic for at least 2 weeks. They will give regular blood, urine and stool samples during their stay and will be closely monitored. The men will return to the clinic about 1 week later for a final safety check.
Trial Details
NCT Number NCT07773129
Lead Sponsor Astellas Pharma Global Development, Inc.
Conditions Healthy Volunteer
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov