A Study to Learn How ASP3082 is Processed in Healthy Men
Condition(s) studied
Investigational drug(s) / intervention(s)
14C-labeled ASP3082: Intravenous infusion
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.
Eligibility
Primary outcome measure(s)
- 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) — Up to 21 days
AUCinf will be recorded from the PK whole blood samples collected. - PK of 14C-labeled ASP3082 (radioactivity in whole blood): area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast) — Up to 21 days
AUClast will be recorded from the PK whole blood samples collected. - PK of 14C-labeled ASP3082 (radioactivity in whole blood): maximum concentration (Cmax) — Up to 21 days
Cmax will be recorded from the PK whole blood samples collected. - PK of 14C-labeled ASP3082 (radioactivity in plasma): AUCinf — Up to 21 days
AUCinf will be recorded from the PK plasma samples collected. - PK of 14C-labeled ASP3082 (radioactivity in plasma): AUClast — Up to 21 days
AUClast will be recorded from the PK plasma samples collected. - PK of 14C-labeled ASP3082 (radioactivity in plasma): Cmax — Up to 21 days
Cmax will be recorded from the PK plasma samples collected. - PK of 14C-labeled ASP3082 (radioactivity ratio of whole blood/plasma concentrations): radioactivity ratio of area under the concentration time curve in blood as compared to plasma (AUCblood/AUCplasma) — Up to 21 days
AUCblood/AUCplasma will be recorded from PK whole blood and plasma samples collected. - Excretion of 14C-labeled ASP3082 (radioactivity in urine): amount of administered dose excreted (Ae) — Up to 21 days
Ae will be recorded from urine samples collected. - Excretion of 14C-labeled ASP3082 (radioactivity in urine): percentage of administered dose excreted (Ae percentage) — Up to 21 days
Ae percentage will be recorded from urine samples collected. - Excretion of 14C-labeled ASP3082 (radioactivity in urine): cumulative (over more than 1 sampling interval) amount of administered dose excreted (CumAe) — Up to 21 days
CumAe will be recorded from urine samples collected. - Excretion of 14C-labeled ASP3082 (radioactivity in urine): renal clearance (CLr) — Up to 21 days
CLr will be recorded from urine samples collected. - Excretion of 14C-labeled ASP3082 (radioactivity in feces): Ae — Up to 21 days
Ae will be recorded from feces samples collected. - Excretion of 14C-labeled ASP3082 (radioactivity in feces): Ae percentage — Up to 21 days
Ae percentage will be recorded from feces samples collected. - Excretion of 14C-labeled ASP3082 (radioactivity in feces): CumAe — Up to 21 days
CumAe will be recorded from feces samples collected. - Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): Ae — Up to 21 days
Combined Ae will be recorded from urine and feces samples collected. - Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): Ae percentage — Up to 21 days
Combined Ae percentage will be recorded from urine and feces samples collected. - Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): CumAe — Up to 21 days
Combined CumAe will be recorded from urine and feces samples collected.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fortrea Clinical Research Unit Inc. | Madison | Wisconsin | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07773129 on ClinicalTrials.gov ↗ ← All trials in the USA