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

An Open, Single Dose Designed Clinical Study to Evaluate Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of URC102 in Patients With Renal Impairment Under Fasted Conditions and Healthy Adult Volunteers Under Fasted and Fed Conditions

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.

Inclusion Criteria:

For Test Group 1 and 2 - subjects with renal impairment

1. Age 19~65
2. BMI 18.0~30.0 kg/m^2 (Body mass index)
3. 30 ≤ eGFR < 60 mL/min/1.73m^2 (estimated glomerular filtration rate)
4. voluntarily given written informed consent

For Control Group - healthy subjects

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

Exclusion Criteria:

For Test Group 1 and 2 - subjects with renal impairment

1. Medical history

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

2. 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

3. Drug hypersensitivity and drug abuse

For Control Group - healthy subjects

1. Medical history

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

2. Clinical examination

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

3. Drug hypersensitivity and drug abuse