A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.
This study consists of two parts; single and multiple administration parts. In single administration part, multiple dose levels of ASP015K or placebo are administered to Japanese and Caucasian men to evaluate whether there is ethnic differences in the pharmacokinetics and pharmacodynamics of ASK015K. In multiple administration part, drugs are administered only to Japanese volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
72
oral
oral
Unnamed facility
Kyushu, Japan
Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests
Time frame: For 48 hours after administration
Plasma unchanged drug concentration
Time frame: For 48 hours after administration
Urinary unchanged drug concentration
Time frame: For 48 hours after administration
Transcription factor phosphorylation level
Time frame: For 48 hours after administration
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