NCT05198778已完成1 期
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
JW Pharmaceutical2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年11月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102
研究概览
简要总结
A phase 1 clinical trial to evaluate safety, PK/PD profiles and food effects of URC102 in patients with renal impairment and healthy people.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Test Group 1 and 2 - subjects with renal impairment
- •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
- •BMI 18.0~30.0 kg/m^2
- •eGFR ≥ 90 mL/min/1.73m^2
- •voluntarily given written informed consent
排除标准
- •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
研究组 & 干预措施
Test group 1: Renal impairment patient
Experimental
Administer URC102, single-dose
干预措施: URC102 (Drug)
Test group 2: Renal impairment patient
Experimental
Administer URC102, single-dose
干预措施: URC102 (Drug)
Control group: Healthy adult people
Experimental
Administer URC102, 2 doses
干预措施: URC102 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102
时间窗: 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
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours
Pharmacokinetic parameter
次要结局
- Number of participants with clinical significant results of Physical examination(up to 2 weeks)
- Serum uric acid(0, 2, 4, 6, 8, 10, 24, 48, 72 hours)
- Excretion amount of uric acid(0, 2, 4, 6, 8, 10, 24, 48, 72 hours)
- Number of participants with clinical significant results of Vital signs(up to 2 weeks)
- Number of participants with treatment-related adverse events(up to 2 weeks)
- Number of participants with clinical significant results of Laboratory tests(up to 2 weeks)
研究者
研究点 (2)
Loading locations...
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