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.

Study Overview

• Status: Completed
• Conditions: Healthy, Renal Impairment
• Intervention / Treatment: Drug: URC102

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheongju, Korea, Republic of
    • Chungbuk National University Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group 1: Renal impairment patient; Administer URC102, single-dose	Drug: URC102; tablet
Experimental: Test group 2: Renal impairment patient; Administer URC102, single-dose	Drug: URC102; tablet
Experimental: Control group: Healthy adult people; Administer URC102, 2 doses	Drug: URC102; tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102	Pharmacokinetic parameter	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours
Maximum concentration of drug in plasma (Cmax) of UR-1102	Pharmacokinetic parameter	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum uric acid	Pharmacodynamic parameter	0, 2, 4, 6, 8, 10, 24, 48, 72 hours
Excretion amount of uric acid	Pharmacodynamic parameter	0, 2, 4, 6, 8, 10, 24, 48, 72 hours
Number of participants with treatment-related adverse events	Safety variable	up to 2 weeks
Number of participants with clinical significant results of Physical examination	Safety variable	up to 2 weeks
Number of participants with clinical significant results of Vital signs	Safety variable	up to 2 weeks
Number of participants with clinical significant results of Laboratory tests	Safety variable	up to 2 weeks

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Min-kyu Park, MD, Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): July 13, 2022
• Study Completion (Actual): July 13, 2022

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 4, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: JW21102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No