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

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy, Renal Impairment

Treatments: Drug: URC102

Study type: Interventional

Funder types: Industry

Identifiers

NCT05198778

JW21102

Details and patient eligibility

About

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

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 3 patient groups

Test group 1: Renal impairment patient

Experimental group

Description:

Administer URC102, single-dose

Treatment:

Drug: URC102

Drug: URC102

Test group 2: Renal impairment patient

Experimental group

Description:

Administer URC102, single-dose

Treatment:

Drug: URC102

Drug: URC102

Control group: Healthy adult people

Experimental group

Description:

Administer URC102, 2 doses

Treatment:

Drug: URC102

Drug: URC102