A Phase 1, Single-Dose, Open Label, Pharmacokinetic and Pharmacodynamic Study of RDEA3170 in Adult Male Subjects With Mild, Moderate, and Severe Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Time of Occurrence of Maximum Observed Concentration (Tmax)
研究概览
简要总结
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m
- •Subject with renal impairment, as determined at Screening, with creatinine clearance as calculated by the Cockcroft-Gault formula of 60 to < 90 mL/min (mild impairment), 30 to < 60 mL/min (moderate impairment), or 15 to < 30 mL/min (severe impairment), or a matched control subject (by age and body mass index) with a creatinine clearance of ≥ 90 mL/min.
- •Subject has a Screening serum urate level ≥ 4.5 mg/dL and ≤ 10 mg/dL
排除标准
- •Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- •Subject has a history or suspicion of kidney stones.
- •Subject has a history of asthma.
- •Subject has undergone major surgery within 3 months prior to Day
- •Subject has donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation
研究组 & 干预措施
Cohort 1: Mild renal impairment
RDEA3170 15 mg once daily fasted
干预措施: RDEA3170 (Drug)
Cohort 2: Moderate renal impairment
RDEA3170 15 mg once daily fasted
干预措施: RDEA3170 (Drug)
Cohort 3: Severe renal impairment
RDEA3170 15 mg once daily fasted
干预措施: RDEA3170 (Drug)
Cohort 4: Control subjects with normal renal function
RDEA3170 15 mg once daily fasted
干预措施: RDEA3170 (Drug)
结局指标
主要结局
Time of Occurrence of Maximum Observed Concentration (Tmax)
时间窗: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
时间窗: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)
时间窗: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function
Apparent Terminal Half-life (t1/2)
时间窗: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function
Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)
时间窗: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Total Body Clearance Corrected for Bioavailability (CL/F)
时间窗: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function
Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)
时间窗: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
次要结局
- Incidence of Treatment-Emergent Adverse Events(5 weeks)
- Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine(Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose))