A Phase 1 Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Febuxostat in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- PK profile of RDEA3170 from plasma and urine and febuxostat from plasma
研究概览
简要总结
This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m
- •no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values, per the Investigator's judgment.
- •a screening serum urate level ≥ 4.5 mg/dL.
排除标准
- •history or suspicion of kidney stones.
- •history of cardiac abnormalities as assessed during screening, including abnormal and clinically relevant electrocardiogram changes and/or family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years.
- •undergone major surgery within 3 months prior to Day
- •donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening Period.
- •inadequate venous access or unsuitable veins for repeated venipuncture.
研究组 & 干预措施
Febuxostat
Days 1-7: febuxostat 40 mg qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.
Days 15-21: RDEA3170 10 mg or placebo qd.
干预措施: RDEA3170 10 mg (Drug)
Febuxostat
Days 1-7: febuxostat 40 mg qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.
Days 15-21: RDEA3170 10 mg or placebo qd.
干预措施: Febuxostat 40 mg (Drug)
Febuxostat
Days 1-7: febuxostat 40 mg qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.
Days 15-21: RDEA3170 10 mg or placebo qd.
干预措施: placebo (Drug)
RDEA3170
Days 1-7: RDEA3170 10 mg or placebo qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.
Days 15-21: febuxostat 40 mg qd.
干预措施: RDEA3170 10 mg (Drug)
RDEA3170
Days 1-7: RDEA3170 10 mg or placebo qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.
Days 15-21: febuxostat 40 mg qd.
干预措施: Febuxostat 40 mg (Drug)
RDEA3170
Days 1-7: RDEA3170 10 mg or placebo qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.
Days 15-21: febuxostat 40 mg qd.
干预措施: placebo (Drug)
结局指标
主要结局
PK profile of RDEA3170 from plasma and urine and febuxostat from plasma
时间窗: Days -1 (urine only), 7, 14, 21 and Days 8, 15, 22 (plasma only)
Profile from plasma and urine in terms of AUC, Tmax, Cmax, t1/2, Ae, and CLr AUC: area under the concentration-time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life; Ae: amount excreted of unchanged drug into urine; CLr: renal clearance
次要结局
- Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters(8 weeks)
- PD profile of RDEA3170 and febuxostat alone and in combination(Days -1, 7, 14, 21 and Days 8, 15, 22 (serum only))