This is a study to investigate the absorption, metabolism and excretion of \[14C\] labeled ASP8273 in subjects with solid tumors harboring EGFR mutations (per local testing). This study consists of two parts (A and B).
This study consists of two parts (A and B). In Part A, eligible subjects will be admitted to the site on day -1 and remain confined at the site until postdosing discharge criteria are met. Subjects will receive a single dose of \[14C\] ASP8273 solution on study day 1. Once Part A has been completed, subjects may elect to continue participation in Part B. Subjects will receive oral administration of ASP8273 (nonradiolabeled) once daily in 28-day cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Oral administration
Oral administration
Part A: Radioactivity in whole blood: AUCinf
AUCinf: area under the concentration-time curve from the time of dosing extrapolated to time infinity
Time frame: Up to 14 days
Part A: Radioactivity in whole blood: AUClast
AUClast: area under the concentration-time curve from the time of dosing to the last measurable concentration
Time frame: Up to 14 days
Part A: Radioactivity in whole blood: Cmax
Cmax: maximum concentration
Time frame: Up to 14 days
Part A: Radioactivity in whole blood: tmax
tmax: time to maximum concentration
Time frame: Up to 14 days
Part A: Radioactivity in whole blood: t1/2
t1/2: apparent terminal elimination half-life
Time frame: Up to 14 days
Part A: Radioactivity in plasma: AUCinf
Time frame: Up to 14 days
Part A: Radioactivity in plasma: AUClast
Time frame: Up to 14 days
Part A: Radioactivity in plasma: Cmax
Time frame: Up to 14 days
Part A: Radioactivity in plasma: tmax
Time frame: Up to 14 days
Part A: Radioactivity in plasma: t1/2
Time frame: Up to 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Part A: Radioactivity ratio for whole blood/plasma concentration (per time point.)
Time frame: Up to 14 days
Part A: Radioactivity ratio for whole blood/plasma AUCinf
Time frame: Up to 14 days
Part A: Radioactivity ratio for whole blood/plasma AUClast
Time frame: Up to 14 days
Part A: Excretion ratio of radioactivity in urine
Time frame: Up to 14 days
Part A: Cumulative excretion of radioactivity in urine
Time frame: Up to 14 days
Part A: Excretion ratio of radioactivity in feces
Time frame: Up to 14 days
Part A: Cumulative excretion of radioactivity in feces
Time frame: Up to 14 days
Part A: Total excretion ratio of radioactivity in urine and feces
Time frame: Up to 14 days
Part A: Total cumulative excretion of radioactivity in urine and feces
Time frame: Up to 14 days
Part A: Radioactivity in emesis (if applicable)
Time frame: Up to 14 days
Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: AUCinf
Time frame: Up to 14 days
Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: AUClast
Time frame: Up to 14 days
Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: Cmax
Time frame: Up to 14 days
Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: tmax
Time frame: Up to 14 days
Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: t1/2
Time frame: Up to 14 days
Part A: Pharmacokinetics of ASP8273 and possible metabolites in urine: (Aelast)
Aelast: cumulative amount of drug excreted from time of dosing up to the collection time of the last measurable concentration
Time frame: Up to 14 days
Part A: Pharmacokinetics of ASP8273 and possible metabolites in urine CLr
CLr: renal clearance
Time frame: Up to 14 days
Part A: Pharmacokinetics of ASP8273 and possible metabolites in urine: % of dose excreted (Aelast%)
Time frame: Up to 14 days
Part A: Profiling of possible metabolites of ASP8273 in plasma
Identification and possible quantification of metabolites in plasma
Time frame: Up to 14 days
Part A: Profiling of possible metabolites of ASP8273 in urine
Identification and possible quantification of metabolites in urine
Time frame: Up to 14 days
Part A: Profiling of possible metabolites of ASP8273 in feces
Identification and possible quantification of metabolites in feces
Time frame: Up to 14 days
Part A and Part B: Safety profile assessed by adverse event reporting, vital signs, electrocardiograms (ECG), clinical laboratory tests, and physical examinations
Vital signs include oral temperature, pulse, and blood pressure. Clinical laboratory evaluations include hematology, chemistry and urinalysis.
Time frame: Up to 36 months