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 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
Excretion amount of uric acid 0, 2, 4, 6, 8, 10, 24, 48, 72 hours Pharmacodynamic parameter
Trial Locations
- Locations (2)
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Chungbuk National University Hospital🇰🇷Cheongju, Korea, Republic of