To investigate the safety, pharmacokinetics and pharmacodynamics of TS-143 when administered 3 times a day for 10 days to healthy Japanese adult males using placebo-controlled, double-blind, dose escalation study design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
24
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan
Incidence of subjects with adverse events
To evaluate the safety of TS-143 given single administration in healthy volunteers by incidence of subjects with adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters.
Time frame: 18 days
Plasma concentrations of unchanged form (ng/mL)
Time frame: 13 days
Urinary excretions of unchanged form (ng/mL)
Time frame: 12 days
Serum EPO concentration
Time frame: 13 days
Reticulocyte count
Time frame: 13 days
Plasma vascular endothelial growth factor (VEGF) concentration
Time frame: 13 days
Serum iron (μg/dL)
Time frame: 13 days
Total iron binding capacity(μg/dL)
Time frame: 13 days
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