An Open-label, Fixed Sequence, Two-period Study to Evaluate the Effects of Repeated Doses of DS-8500a on the Pharmacokinetics of Rosuvastatin in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatin
研究概览
简要总结
The primary purpose of this study is to assess the effect of repeated doses of DS-8500a on the single dose pharmacokinetics (PK) of rosuvastatin.
The total length of time (from screening to follow-up) for each participant is approximately 7 weeks.
It is expected that repeated oral doses of DS-8500a will not have a significant effect on the pharmacokinetics of a single dose of rosuvastatin.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is healthy and of non-child-bearing potential
- •Has a body mass index of 18-30 kg/m^2
- •Has negative results for drugs of abuse, cotinine (smoking) and alcohol at screening
- •Has signed informed consent and agreed to comply with all study requirements
排除标准
- •Has history or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine/metabolic, neurologic, infectious, gastrointestinal , hematologic, or oncologic disease as determined by screening history, physical examination, laboratory test results, or 12-lead ECG
- •Has any other condition detailed in the protocol, or that in the opinion of the Investigator, precludes participation in the study
研究组 & 干预措施
All Participants
In treatment Period 1 (Day 1 through Day 4), on Day 1, participants receive a single dose of rosuvastatin 10 mg orally with food, and in Period 2 (Day 1 through Day 16), starting on Day 1, participants receive DS-8500a 75 mg orally qd with food for 16 days with concomitant administration of a single dose of rosuvastatin 10 mg qd on Day 14.
In both the periods, rosuvastatin and DS-8500a are administered after an overnight fast of 8 hours and within 10 minutes after consuming a standardized breakfast of 500 calories.
干预措施: DS-8500a (Drug)
All Participants
In treatment Period 1 (Day 1 through Day 4), on Day 1, participants receive a single dose of rosuvastatin 10 mg orally with food, and in Period 2 (Day 1 through Day 16), starting on Day 1, participants receive DS-8500a 75 mg orally qd with food for 16 days with concomitant administration of a single dose of rosuvastatin 10 mg qd on Day 14.
In both the periods, rosuvastatin and DS-8500a are administered after an overnight fast of 8 hours and within 10 minutes after consuming a standardized breakfast of 500 calories.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatin
时间窗: on Day 1 of Period 1 and Day 14 of Period 2
Time of maximum observed concentration (Tmax) for single dose rosuvastatin
时间窗: on Day 1 of Period 1 and Day 14 of Period 2
Area under the plasma concentration time curve (AUC) from time 0 to the last quantifiable concentration (AUClast) for single dose rosuvastatin
时间窗: on Day 1 of Period 1 and Day 14 of Period 2
次要结局
- Cmax for DS-8500a and its metabolites(on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2)
- Tmax for DS-8500a and its metabolites(on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2)
- AUC from time 0 to 24 hours (AUC0-24) for DS-8500a and its metabolites(on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2)
- Metabolite to parent (M:P) AUC0-24 ratios for DS-8500a and its metabolites(on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2)
- Cmax at steady state (Cmax,ss)(Day 16 of Period 2)
- AUC during the 24 hour dosing interval (AUCtau)(Day 16 of Period 2)
- Tmax at steady state (Tmax,ss)(Day 16 of Period 2)
- Minimum observed analyte concentration that was just prior to the beginning of the dosing interval (Ctrough)(Days 2, 3, 5, 7, 10, 14, and 16 of Period 2)
- Accumulation ratio (AccRatio)(Day 16 of Period 2)