A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment

This trial will evaluate

• in patients with renal impairment: the safety, pharmacokinetics and pharmacodynamics after single oral administration of URC102 under fasted conditions.
• 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.

Inclusion criteria

For Test Group 1 and 2 - subjects with renal impairment

• Age 19~65
• BMI 18.0~30.0 kg/m^2 (Body mass index)
• 30 ≤ eGFR < 60 mL/min/1.73m^2 (estimated glomerular filtration rate)
• voluntarily given written informed consent

For Control Group - healthy subjects

• Age ≥ 19
• BMI 18.0~30.0 kg/m^2
• eGFR ≥ 90 mL/min/1.73m^2
• voluntarily given written informed consent

Exclusion criteria

For Test Group 1 and 2 - subjects with renal impairment

• Medical history

• Subjects with lactic acidosis or marked hepatotoxicity
• Not controlled diabetes, hypertension, dyslipidemia
• requiring dialysis
• Clinical examination

• AST, ALT > 2, Bilirubin total, γ-GTP > 1.5, CK > 2 times the upper limit of normal ranges (Aspartate transaminase, Alanine transaminase, gamma-Glutamyl transpeptidase, Creatine phosphokinase)
• Positive serologic results
• Drug hypersensitivity and drug abuse

For Control Group - healthy subjects

• Medical history

• History of chronic liver disease, hepatic encephalopathy, ascites, or upper gastrointestinal bleeding
• Subjects with lactic acidosis or marked hepatotoxicity
• Clinical examination

• AST, ALT > 2, Bilirubin total, γ-GTP > 1.5, CK > 2 times the upper limit of normal ranges
• Positive serologic results
• Drug hypersensitivity and drug abuse