To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of \[14C\]TAS-303 following oral single dose
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
oral administration on day 1
A site selected by Taiho Pharmaceutical Co., Ltd.
Tokyo, Japan
Concentrations of total radioactivity in blood and plasma
Time frame: Day1 to 8 and 10,12,14,16,18,20,22
Plasma TAS-303 concentrations
Time frame: Day1 to 8 and 10,12,14,16,18,20,22
Maximum plasma concentration (Cmax)
Time frame: Day1 to 8 and 10,12,14,16,18,20,22
Area under the plasma concentration versus time curve (AUC).
Time frame: Day1 to 8 and 10,12,14,16,18,20,22
Elimination half life (T1/2)
Time frame: Day1 to 8 and 10,12,14,16,18,20,22
Radioactivity cumulative excretion rate into urine
Time frame: Day 1 to Day 22
Radioactivity cumulative excretion rate into feces.
Time frame: Day 1 to Day 22
Radioactivity excretion and excretion rate,cumulative excretion, cumulative excretion rate in all excreta (urine and feces).
Time frame: Day 1 to Day 22
Adverse events
The number and incidence of Adverse events.
Time frame: Day 1 to Day 29
Treatment-related adverse events
The number and incidence of Treatment-related adverse events.
Time frame: Day 1 to Day 29
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Number of Participants With Abnormal Laboratory Values
Time frame: Screening period and Day -2, 8, 15, 22, 29
Blood Pressure
Time frame: Screening period and Day 1, 2, 8, 15, 22, 29
Pulse rate
Time frame: Screening period and Day 1, 8, 15, 22, 29
Temperature
Time frame: Screening period and Day 1, 2, 8, 15, 22, 29
QTc interval
Time frame: Screening period and Day 1, 8, 15, 22, 29
Heart rate
Time frame: Screening period and Day 1, 8, 15, 22, 29