A Phase 2a Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamic (PD) Effects of LLX-424 in Patients With a History of Kidney Stones
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- Treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase 2a study of glycolate oxidase inhibitor LLX-424 in patients with a history of kidney stones. Eligible subjects with a history of kidney stones will be randomized to receive study drug (LLX-424 or placebo) for 8 weeks.
详细描述
This is a Phase 2a, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK, and PD effects of LLX-424 in patients with a history of kidney stones.
Following completion of screening procedures, on Study Day 1, eligible subjects will be randomized in a 2:1 ratio to receive either LLX-424 or matching placebo, respectively.
An outpatient safety Follow-up Visit will be scheduled on Day 63 or 7 days after the last dose (end of study visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of kidney stones documented in medical records
- •24-hour urine oxalate excretion
- •Body mass index 18.5 to 38 kg/m2 inclusive
- •Estimated glomerular filtration rate ≥ 60 mL/min/1.73m2
排除标准
- •History or medical record evidence of kidney stones that are not calcium oxalate
- •Unstable kidney function
- •Spot urine protein to creatinine ratio ≥ 1 mg/mg at screening
- •History of kidney transplantation
- •Hemoglobin A1c > 9.5% at screening
- •History of enteric hyperoxaluria, intestinal malabsorption, bariatric surgery, intestinal surgery, inflammatory bowel disease
- •History or evidence of cirrhosis
研究组 & 干预措施
LLX-424
Tablets for oral administration
干预措施: LLX-424 (Drug)
Placebo
Tablets for oral administration
干预措施: LLX-424 (Drug)
结局指标
主要结局
Treatment-emergent adverse events (TEAEs)
时间窗: From the first dose and for up to 9 weeks
Percentage of subjects with TEAEs
Percentage of subjects with study drug-related severe laboratory-based AEs
时间窗: From the first dose and for up to 9 weeks
Laboratory-based adverse events
QT interval on ECG
时间窗: From the first dose and for up to 9 weeks
Percentage of subjects with an increase from baseline in the QTcF by \> 60 milliseconds
次要结局
- Mean change from baseline in 24-hour urine oxalate excretion rate(From pre-dose to Study Day 56)
- Peak plasma concentration (Cmax) of LLX-424(From pre-dose to Study Day 56)
- Area under the curve (AUC) of plasma LLX-424 concentration versus time after dosage(From pre-dose to Study Day 56)
- Peak plasma concentration (Cmax) of glycolate(From pre-dose to Study Day 56)
- Area under the curve (AUC) of plasma glycolate concentration versus time after dosage(From pre-dose to Study Day 56)