The purpose of this study is to evaluate the influence of repeated oral doses of KW-6356 on the pharmacokinetics of index substrates for CYP3A4/5, CYP1A2 and BCRP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.
In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.
In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.
Fukuoka Mirai Hospital Clinical Research Center
Fukuoka, Japan
Geometric mean ratio of the major pharmacokinetic parameter (AUC0-t) of the index substrates in combination with or without KW-6356
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of the index substrates in combination with or without KW-6356
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of the index substrates in combination with or without KW-6356
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (tmax) of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (CL/F) of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (Vz/F) of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (t1/2) of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
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In Period 2, Day 4-13(except Day11) a single dose of KW-6356 will be administered after breakfast, Day 11 a single dose of KW-6356 will be administered after fasting for at least 10 hours.
Plasma concentrations of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Plasma concentrations of KW-6356
Time frame: Starting around 2 hours before intake of KW-6356 and continued until 24 hours after the last dose of KW-6356
Incidence of treatment-emergent adverse events
Time frame: Starting 24 or 48 hours before intake of the index substrates and continued until 8 days after the last dose of KW-6356