A Phase 1b, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Allopurinol in Adult Male Subjects With Gout
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
研究概览
简要总结
This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
- •Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m
- •Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
- •Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
排除标准
- •Subject is unable to take colchicine for gout flare prophylaxis.
- •Subject has a history or suspicion of kidney stones.
- •Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -
- •Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
- •Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is stable for at least 14 days prior to study medication dosing.
- •Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.
研究组 & 干预措施
Sequence A
RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd
干预措施: RDEA3170 10 mg (Drug)
Sequence A
RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd
干预措施: allopurinol 300 mg (Drug)
Sequence B
allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd
干预措施: RDEA3170 10 mg (Drug)
Sequence B
allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd
干预措施: allopurinol 300 mg (Drug)
结局指标
主要结局
Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
时间窗: 22 days
CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Maximum Observed Plasma Concentration (Cmax)
时间窗: 22 days
Cmax of RDEA3170 Alone and In Combination with Allopurinol
Time of Occurrence of Maximum Observed Concentration (Tmax)
时间窗: 22 days
Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
时间窗: 22 days
AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
时间窗: 22 days
AUC last of RDEA3170 Alone and In Combination with Allopurinol
Apparent Terminal Half-life (t1/2)
时间窗: 22 days
t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
时间窗: 22 days
Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
时间窗: 22 days
次要结局
- Incidence of Treatment-Emergent Adverse Events(22 days)