To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
40
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan
Incidence of adverse events
To evaluate the safety of TS-143 given single administration in healthy volunteers by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters.
Time frame: 8 days
Plasma concentrations of unchanged form (ng/mL)
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.
Time frame: 72 hours
Urinary excretions of unchanged form (ng/mL)
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group.
Time frame: 72 hours
Serum erythropoietin (EPO) concentration
Time frame: 72 hours
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