Randomized, open, single ascending dose, parallel study to evaluate the pharmacokinetics, pharmacodynamics and safety of KRN1493 after single oral administration in healthy Korean male volunteers.
Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug orally with 240 ml water around at 9 a.m. of Day 1 and they were fasted until 4 hours post-dose. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic samplings. During admission, subjects were served low calcium diets. Subjects were discharged on Day 2, and visited Clinical Trials Center on Day 3, Day 4 and Day 5. Study participation was terminated on post-study visit (Day 7 - 10).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
KRN1493 25mg tablet 2,3 or 4 tablets single oral administration
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea
Plasma KRN1493 concentration
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours after dosing
Plasma PTH concentration
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
Albumin corrected plasma calcium concentration
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
Plasma phosphorus concentration
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
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