A Phase 1, Randomized, Open-Label Study in Healthy Adult Male Subjects to Assess the Pharmacokinetics and Pharmacodynamics of RDEA3170
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m
- •Subject has a Screening serum urate level 4 to 7 mg/dL
- •Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
排除标准
- •Subject has a history or suspicion of kidney stones.
- •Subject has undergone major surgery within 3 months prior to Screening.
- •Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day
- •Subject has clinically unacceptable physical examination, per the Investigator's judgment.
- •Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
- •Subject has Screening clinical safety laboratory parameters (serum chemistry [other than serum creatinine and serum urate], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
- •Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
- •Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
- •Subject has a history of cardiac abnormalities
- •Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.
研究组 & 干预措施
Single Dose
Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
干预措施: RDEA3170 12 mg (Drug)
Single Dose
Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
干预措施: RDEA3170 4.5 mg (Drug)
Single Dose
Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
干预措施: RDEA3170 6 mg (Drug)
Multiple Dose
RDEA3170 12 mg once daily (qd)
干预措施: RDEA3170 12 mg (Drug)
Single Dose Food Effect
Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8.
干预措施: RDEA3170 6 mg (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Urine uric acid excretion amount
时间窗: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Renal clearance of uric acid
时间窗: Days -1, 1 and 7
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Fractional excretion of uric acid
时间窗: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Renal Clearance of Uric Acid
时间窗: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Cmax
时间窗: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Time of Occurrence of maximum observed concentration (Tmax)
时间窗: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Area under the plasma concentration time curve (AUC)
时间窗: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
AUC
时间窗: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Tmax
时间窗: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Serum urate concentration
时间窗: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
次要结局
- Incidence of Adverse Events in terms of changes in laboratory parameters(6 weeks)
- Incidence of Adverse Events in terms of electrocardiogram parameters(6 weeks)
- Incidence of Adverse Events in terms of vital signs(6 weeks)
- Incidence of Adverse Events in terms of physical examination findings(6 weeks)
- Apparent terminal half-life (t1/2)(Days -1, 1, 5 and 9)
- t1/2(Days -1, 1 and 7)