The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered. The effect of food on PK/PD of FYU-981 is also investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
54
Subjects randomized to the FYU-981 arm receive active drug, FYU-981.
Subjects randomized to the placebo arm receive placebo.
Japan
Tokyo, Japan
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time frame: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time frame: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time frame: 48 hours
Pharmacokinetics (MRT: Mean residence time)
Time frame: 48 hours
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time frame: 48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time frame: 48 hours
Pharmacokinetics (CLr: Renal clearance)
Time frame: 48 hours
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