Healthy, Renal Impairment
Conditions
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.
Interventions
DRUGURC102
tablet
Sponsors
JW Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel study between groups (crossover study within healthy patients)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events | up to 2 weeks | Safety variable |
| 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 Laboratory tests | up to 2 weeks | Safety variable |
| Number of participants with clinical significant results of Vital signs | up to 2 weeks | Safety variable |
| Excretion amount of uric acid | 0, 2, 4, 6, 8, 10, 24, 48, 72 hours | Pharmacodynamic parameter |
Countries
South Korea
Outcome results
None listed