A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout

Ardea Biosciences, Inc.0 个研究点目标入组 41 人开始时间: 2015年7月28日最近更新: 2018年1月23日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Ardea Biosciences, Inc.
入组人数: 41
主要终点: Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
•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.
•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 any gastrointestinal disorder that affects motility and/or absorption.
•Subject had unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.
•Subject has Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
•Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
•Subject is taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are 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

RDEA3170 2.5 mg, 7.5 mg and 15 mg

Experimental

RDEA3170 2.5 mg, 7.5 mg and 15 mg once daily (qd) in combination with allopurinol 300 mg (qd and twice daily (bid))

干预措施: RDEA3170 2.5 mg (Drug)

RDEA3170 2.5 mg, 7.5 mg and 15 mg

Experimental

RDEA3170 2.5 mg, 7.5 mg and 15 mg once daily (qd) in combination with allopurinol 300 mg (qd and twice daily (bid))

干预措施: allopurinol 300 mg (Drug)

RDEA3170 5 mg, 10 mg and 20 mg

Experimental

RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)

干预措施: RDEA3170 2.5 mg (Drug)

RDEA3170 5 mg, 10 mg and 20 mg

Experimental

RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)

干预措施: allopurinol 300 mg (Drug)

结局指标

主要结局

Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))