A phase 1 clinical trial to evaluate safety, PK/PD profiles and food effects of URC102 in patients with renal impairment and healthy people.
This trial will evaluate 1. in patients with renal impairment: the safety, pharmacokinetics and pharmacodynamics after single oral administration of URC102 under fasted conditions. 2. in healthy adult subjects: the safety, pharmacokinetics and pharmacodynamics of 2 single doses of URC102 in the morning after fasting or after a high-fat breakfast. The 2 doses will be separated by a washout period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Chungbuk National University Hospital
Cheongju-si, South Korea
Ajou University Hospital
Suwon, South Korea
Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102
Pharmacokinetic parameter
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours
Maximum concentration of drug in plasma (Cmax) of UR-1102
Pharmacokinetic parameter
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours
Serum uric acid
Pharmacodynamic parameter
Time frame: 0, 2, 4, 6, 8, 10, 24, 48, 72 hours
Excretion amount of uric acid
Pharmacodynamic parameter
Time frame: 0, 2, 4, 6, 8, 10, 24, 48, 72 hours
Number of participants with treatment-related adverse events
Safety variable
Time frame: up to 2 weeks
Number of participants with clinical significant results of Physical examination
Safety variable
Time frame: up to 2 weeks
Number of participants with clinical significant results of Vital signs
Safety variable
Time frame: up to 2 weeks
Number of participants with clinical significant results of Laboratory tests
Safety variable
Time frame: up to 2 weeks
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