A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment
- Registration Number
- NCT05198778
- Lead Sponsor
- JW Pharmaceutical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group: Healthy adult people URC102 Administer URC102, 2 doses Test group 1: Renal impairment patient URC102 Administer URC102, single-dose Test group 2: Renal impairment patient URC102 Administer URC102, single-dose
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours Pharmacokinetic parameter
Maximum concentration of drug in plasma (Cmax) of UR-1102 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours Pharmacokinetic parameter
- Secondary Outcome Measures
Name Time Method Excretion amount of uric acid 0, 2, 4, 6, 8, 10, 24, 48, 72 hours Pharmacodynamic parameter
Number of participants with clinical significant results of Physical examination up to 2 weeks Safety variable
Serum uric acid 0, 2, 4, 6, 8, 10, 24, 48, 72 hours Pharmacodynamic parameter
Number of participants with clinical significant results of Vital signs up to 2 weeks Safety variable
Number of participants with treatment-related adverse events up to 2 weeks Safety variable
Number of participants with clinical significant results of Laboratory tests up to 2 weeks Safety variable
Trial Locations
- Locations (2)
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of