A Phase 1 Study to Evaluate the Potential Two-Way Pharmacokinetic Interaction Between Lesinurad and Naproxen and Between Lesinurad and Indomethacin in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- PK profile of naproxen and indomethacin from plasma and urine
研究概览
简要总结
This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroidal anti-inflammatory drugs.
详细描述
Naproxen and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs) used both prophylactically for the prevention of, and as a treatment for, acute gout flares. RDEA594-126 is an open-label study designed to assess the potential effect of multiple doses of naproxen and indomethacin on the single-dose PK of lesinurad, and to assess the potential effect of multiple doses of lesinurad on the multiple-dose PK of naproxen and indomethacin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（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 (BMI) ≥ 18 and ≤ 30 kg/m
- •Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
- •Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.
排除标准
- •Subject has clinically significant 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 within 4 weeks prior to the Screening visit.
- •Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
研究组 & 干预措施
Lesinurad 400 mg and naproxen 250 mg
Lesinurad once daily (qd) Day 1, naproxen twice daily (bid) Day 2-6, lesinurad qd with naproxen bid Day 7-14.
干预措施: lesinurad 400 mg (Drug)
Lesinurad 400 mg and naproxen 250 mg
Lesinurad once daily (qd) Day 1, naproxen twice daily (bid) Day 2-6, lesinurad qd with naproxen bid Day 7-14.
干预措施: naproxen 250 mg (Drug)
Lesinurad 400 mg and indomethacin 25 mg
Lesinurad qd Day 1, indomethacin bid Day 2-6, lesinurad qd with indomethacin bid Day 7-14.
干预措施: lesinurad 400 mg (Drug)
Lesinurad 400 mg and indomethacin 25 mg
Lesinurad qd Day 1, indomethacin bid Day 2-6, lesinurad qd with indomethacin bid Day 7-14.
干预措施: indomethacin 25 mg (Drug)
结局指标
主要结局
PK profile of naproxen and indomethacin from plasma and urine
时间窗: Day 1, Day 6 (urine only), Day 7, Day 14
Profile in terms of AUC, Tmax, Cmax, and t1/2
PK profile of lesinurad from plasma and urine
时间窗: Day 1, Day 6 (urine only), Day 7, Day 14
Profile in terms of AUC, Tmax, Cmax, and t1/2 AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life
次要结局
- Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters(13 weeks)