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

Study Overview
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Brief Summary
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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
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This trial will evaluate in patients with renal impairment: the safety, pharmacokinetics and pharmacodynamics after single oral administration of URC102 under fasted conditions. 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.

Official Title
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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

Conditions
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Healthy, Renal Impairment

Intervention / Treatment
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* Drug: URC102
* Drug: URC102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Test Group 1 and 2 - subjects with renal impairment Age 19 65 BMI 18.0 30.0 kg/m^2 (Body mass index) 30 ≤ eGFR < 60 mL/min/1.73m^2 (estimated glomerular filtration rate) voluntarily given written informed consent For Control Group - healthy subjects Age ≥ 19 BMI 18.0 30.0 kg/m^2 eGFR ≥ 90 mL/min/1.73m^2 voluntarily given written informed consent Exclusion Criteria: For Test Group 1 and 2 - subjects with renal impairment Medical history Subjects with lactic acidosis or marked hepatotoxicity Not controlled diabetes, hypertension, dyslipidemia requiring dialysis 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 Drug hypersensitivity and drug abuse For Control Group - healthy subjects Medical history History of chronic liver disease, hepatic encephalopathy, ascites, or upper gastrointestinal bleeding Subjects with lactic acidosis or marked hepatotoxicity Clinical examination AST, ALT > 2, Bilirubin total, γ-GTP > 1.5, CK > 2 times the upper limit of normal ranges Positive serologic results Drug hypersensitivity and drug abuse

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel study between groups (crossover study within healthy patients)
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |