A Phase 1, Randomized, Open-Label, Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability and Food Effect of Various Formulations of RDEA3170
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Time of Occurrence of Maximum Observed Concentration (Tmax)
研究概览
简要总结
The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.
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
- 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 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 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 of 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 cannot swallow multiple tablets or capsules.
- •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
Treatment I
RDEA3170, 10 mg (FN26), administered in the fasted state.
干预措施: RDEA3170, 10 mg (Drug)
Treatment A
RDEA3170, 5 mg (FN24), administered in the fasted state.
干预措施: RDEA3170, 5 mg (Drug)
Treatment B
RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal).
干预措施: RDEA3170, 5 mg (Drug)
Treatment C
RDEA3170, 10 mg (FN25), administered in the fasted state.
干预措施: RDEA3170,10 mg (Drug)
Treatment D
RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal).
干预措施: RDEA3170,10 mg (Drug)
Treatment E
RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
干预措施: RDEA3170, 2.5 mg (Drug)
Treatment J
RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
干预措施: RDEA3170, 10 mg (Drug)
Treatment K
RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
干预措施: RDEA3170, 2.5 mg (Drug)
结局指标
主要结局
Time of Occurrence of Maximum Observed Concentration (Tmax)
时间窗: Day 1, 5, 9, 13, 17
Tmax is the time of occurrence of cmax
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
时间窗: Day 1, 5, 9, 13, 17
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Apparent Terminal Half-life (t1/2)
时间窗: Day 1, 5, 9, 13, 17
t1/2 is a measure of apparent terminal half-life
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day 1, 5, 9, 13, 17
Cmax is the maximum observed concentration of a drug after administration
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
时间窗: Day 1, 5, 9, 13, 17
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules
时间窗: Day 1, 5, 9, 13, 17
Cmax is the maximum observed concentration of a drug after administration
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules
时间窗: Day 1, 5, 9, 13, 17
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
时间窗: Day 1, 5, 9, 13, 17
AUC 0-∞ is a meausre of total concentration from time zero to infinity
次要结局
- Incidence of Treatment-Emergent Adverse Events(8 weeks)
- Pharmacodynamics (PD) Profile of RDEA3170(Day -1, 1, 5, 9, 13, 17)