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A Study to Learn How ASP3082 is Processed in Healthy Men

NCT07773129 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-08-19

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

14C-labeled ASP3082

Intravenous infusion

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773129 on ClinicalTrials.gov