NCT02760342已完成1 期
ASP015K Pharmacokinetic Study: Evaluation of Drug-Drug Interaction Between ASP015K and Metformin
适应症
干预措施
相关药物
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
- Pharmacokinetics (PK) parameter of metformin in plasma: AUCinf
研究概览
简要总结
The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K and metformin in healthy non-elderly male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight at screening: ≥ 50.0 kg, < 80.0 kg
- •BMI at screening: ≥ 17.6, < 26.4
- •Subjects who agree to use highly effective contraception as consisting of two forms of birth control (at least one of which must be a barrier method) from getting informed consent through 90 days after the final study drug administration.
- •Subjects who agree NOT to donate sperm from getting informed consent through 90 days after the final study drug administration.
排除标准
- •Subjects who received or are scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -1).
- •Subjects who received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission (Day -1).
- •Subjects who received ASP015K or metformin previously.
- •Subjects who have a habit of excessive alcohol drinking or smoking.
- •Any deviation from the normal range of blood pressure, pulse, body temperature, or 12-lead ECG at screening or on the day of hospital admission (Day -1).
- •Subjects who meet any of the following criterion for laboratory tests at screening or on the day of hospital admission (Day -1). Normal ranges of each test specified at the study site or test/assay organization will be used as the normal ranges in this study.
- •Subjects with a complication or history of drug allergies.
- •Subjects who have a history of clinically serious allergy, which induces generalized urticaria or anaphylactic shock requiring hospital admission.
- •Subjects with a complication or history of hepatic disease, renal disease, cardiac disease, congenital short QT syndrome, respiratory disease , gastrointestinal disease.
- •Subjects with a history of gastrointestinal resection.
- •Subjects who developed upper gastrointestinal symptoms within seven days before the hospital admission (Day -1).
- •Subjects with a complication or history of endocrine disease, cerebrovascular disease, malignant tumor, lymphatic disease , lactic acidosis.
- •Subjects who apply to any of the concerns with regard to tuberculosis.
- •Subjects who apply to any of the concerns with regard to infection other than tuberculosis.
- •Subjects with vaccination of live vaccines or live attenuated vaccines within 56 days before the hospital admission (Day -1).
研究组 & 干预措施
ASP015K and Metformin
Experimental
Subjects will receive a single oral dose of metformin on Days 1 and 10, a single dose of ASP015K on Day 3 and multiple doses of ASP015K once daily Day 5 to Day 11. Subjects will receive a single dose of metformin and ASP015K concurrently on Day 10.
干预措施: peficitinib (Drug)
ASP015K and Metformin
Experimental
Subjects will receive a single oral dose of metformin on Days 1 and 10, a single dose of ASP015K on Day 3 and multiple doses of ASP015K once daily Day 5 to Day 11. Subjects will receive a single dose of metformin and ASP015K concurrently on Day 10.
干预措施: Metformin (Drug)
结局指标
主要结局
Pharmacokinetics (PK) parameter of metformin in plasma: AUCinf
时间窗: Up to Day 12
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
PK parameter of metformin in plasma: Cmax
时间窗: Up to Day 12
Cmax: Maximum concentration
PK parameter of metformin in plasma: AUClast
时间窗: Up to Day 12
AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration
次要结局
- PK parameter of metformin in plasma: tmax(Up to Day 12)
- PK parameter of metformin in urine: Aelast(Up to Day 12)
- PK parameter of ASP015K in plasma: AUClast(Up to Day 12)
- PK parameter of ASP015K in plasma: PTR(Up to Day 12)
- PK parameter of metabolites of ASP015K in plasma: tmax(Up to Day 12)
- PK parameter of metformin in urine: CLR(Up to Day 12)
- PK parameter of metabolites of ASP015K in plasma: AUClast(Up to Day 12)
- PK parameter of metabolites of ASP015K in plasma: Rac(Up to Day 12)
- PK parameter of ASP015K in plasma: CL/F(Up to Day 12)
- PK parameter of ASP015K in plasma: Rac(Up to Day 12)
- PK parameter of ASP015K in plasma: t1/2(Up to Day 12)
- PK parameter of ASP015K in plasma: tmax(Up to Day 12)
- PK parameter of metabolites of ASP015K in plasma: AUCtau(Up to Day 12)
- PK parameter of metabolites of ASP015K in plasma: Cmax(Up to Day 12)
- PK parameter of metabolites of ASP015K in plasma: Ctrough(Up to Day 12)
- PK parameter of metformin in plasma: t1/2(Up to Day 12)
- PK parameter of metformin in plasma: Vz/F(Up to Day 12)
- PK parameter of metformin in urine: Aelast%(Up to Day 12)
- PK parameter of ASP015K in plasma: AUCinf(Up to Day 12)
- PK parameter of ASP015K in plasma: Vz/F(Up to Day 12)
- Safety assessed by Adverse events(Up to 17 days after first study drug dosing)
- Number of participants with abnormal laboratory values and/or adverse events related to treatment(Up to 17 days after first study drug dosing)
- Number of participants with abnormal standard 12-lead ECG and/or adverse events related to treatment(Up to 17 days after first study drug dosing)
- PK parameter of metformin in plasma: CL/F(Up to Day 12)
- PK parameter of ASP015K in plasma: AUCtau(Up to Day 12)
- PK parameter of ASP015K in plasma: Cmax(Up to Day 12)
- PK parameter of ASP015K in plasma: Ctrough(Up to Day 12)
- PK parameter of metabolites of ASP015K in plasma: AUCinf(Up to Day 12)
- PK parameter of metabolites of ASP015K in plasma: PTR(Up to Day 12)
- PK parameter of metabolites of ASP015K in plasma: t1/2(Up to Day 12)
- Number of participants with abnormal vital signs and/or adverse events related to treatment(Up to 17 days after first study drug dosing)
研究者
研究点 (1)
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