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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase 1 clinical trial to evaluate safety, PK/PD profiles and food effects of URC102 in patients with renal impairment and healthy people.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: JW Pharmaceutical

Criteria

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