A Study to Learn How ASP3082 is Processed in Healthy Men

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07773129
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 14C-labeled ASP3082 — DRUG
    Intravenous infusion

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Aug 28, 2026
Status verified
Sep 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 14C-labeled ASP3082
    Participants will receive single dose of 14C-labeled ASP3082 on Day 1.

Primary Outcome Measure

Pharmacokinetics (PK) of 14C-labeled ASP3082 (radioactivity in whole blood): area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf) [ Time Frame: Up to 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research Unit Inc.MadisonWisconsin53704-

Find similar trials in Madison, WI

By research site
Fortrea Clinical Research Unit Inc.· Madison, WI

Related Studies