The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
29
Unnamed facility
Lakewood, Colorado, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Number of subjects with adverse events
Time frame: 15 days
Vital signs and 12 lead ECGs
Time frame: 15 days
Cmax (maximum concentration)
Time frame: 15 days
tmax (time to reach maximum concentration)
Time frame: 15 days
t1/2 (elimination half-life)
Time frame: 15 days
AUC (area under the concentration-time curve)
Time frame: 15 days
AR (accumulation ratio)
Time frame: 15 days
RBC (red blood cell) count
Time frame: 15 days
Hgb (hemoglobin)
Time frame: 15 days
TSAT (transferrin saturation)
Time frame: 15 days
serum ferritin
Time frame: 15 days
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Saint Paul, Minnesota, United States