Status:
COMPLETED
A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment
Lead Sponsor:
JW Pharmaceutical
Conditions:
Healthy, Renal Impairment
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
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 adul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05198778
Start Date
November 29 2021
End Date
July 13 2022
Last Update
December 6 2022
Active Locations (2)
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1
Chungbuk National University Hospital
Cheongju-si, South Korea
2
Ajou University Hospital
Suwon, South Korea