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

NCT ID: NCT05198778

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2022-07-13

Brief 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.

Detailed 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.

Conditions

Healthy, Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group 1: Renal impairment patient

Administer URC102, single-dose

Group Type: EXPERIMENTAL

URC102

Intervention Type: DRUG

tablet

Test group 2: Renal impairment patient

Administer URC102, single-dose

Group Type: EXPERIMENTAL

URC102

Intervention Type: DRUG

tablet

Control group: Healthy adult people

Administer URC102, 2 doses

Group Type: EXPERIMENTAL

URC102

Intervention Type: DRUG

tablet

URC102

Intervention Type: DRUG

tablet

Interventions

URC102

tablet

Intervention Type: DRUG

URC102

tablet

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min-kyu Park, MD

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Locations

Chungbuk National University Hospital

Cheongju-si, , South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

JW21102

Identifier Type: -

Identifier Source: org_study_id