Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests
研究概览
简要总结
A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.
详细描述
This study consists of two parts; single and multiple administration parts. In single administration part, multiple dose levels of ASP015K or placebo are administered to Japanese and Caucasian men to evaluate whether there is ethnic differences in the pharmacokinetics and pharmacodynamics of ASK015K. In multiple administration part, drugs are administered only to Japanese volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy judged by the investigator or subinvestigator on the basis of physical examination and all test results
- •Japanese: ≥ 50.0 kg to < 80.0 kg
- •Caucasians: ≥ 50.0 kg to < 100.0 kg
- •Japanese: ≥ 17.6 kg/m2 to < 26.4 kg/m2
- •Caucasians: ≥ 18.0 kg/m2 to < 30.0 kg/m2
- •Written informed consent obtained from the subject personally
排除标准
- •Administered drug in another clinical study or a post-market clinical study in the 120 days prior to the study
- •Collection of 400 mL of whole blood within 90 days prior to the study,
- •200 mL of whole blood within 30 days prior to the study or blood components within 14 days prior to the study
- •Received or is scheduled to receive drug treatment within 7 days prior to the drug administration
- •A history of drug allergies
- •Upper gastrointestinal symptoms, e.g., nausea, vomiting or stomachache, within 7 days prior to the drug admission
- •Concurrent or previous liver disease, e.g., viral hepatitis or drug-induced hepatic injury
- •Concurrent or previous heart disease, e.g., congestive heart failure, angina pectoris or arrhythmias requiring treatment
- •Concurrent or previous kidney disease, e.g., acute renal failure,
- •glomerulonephritis or interstitial nephritis (except for previous urinary
- •Concurrent or previous cerebrovascular disease, e.g., cerebral infarction
- •Concurrent or previous malignancy
- •Concurrent or previous active or recurrent infection, e.g., hepatitis B,
- •hepatitis C or syphilis
研究组 & 干预措施
ASP015K Single Japanese Group
Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level.
干预措施: peficitinib (Drug)
ASP015K Single Caucasian Group
Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level.
干预措施: peficitinib (Drug)
Placebo Single Japanese Group
Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level.
干预措施: Placebo (Drug)
Placebo Single Caucasian Group
Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level.
干预措施: Placebo (Drug)
ASP015K Multiple Group
Participants will receive ASP015K in three stages, each stage corresponding to a different dosage level. ASP015K will be administered at 12-hour intervals after breakfast and dinner for seven days.
干预措施: peficitinib (Drug)
Placebo Multiple Group
Participants will receive placebo in three stages, each stage corresponding to a different dosage level. Placebo will be administered at 12-hour intervals after breakfast and dinner for seven days.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests
时间窗: For 48 hours after administration
次要结局
- Urinary unchanged drug concentration(For 48 hours after administration)
- Plasma unchanged drug concentration(For 48 hours after administration)
- Transcription factor phosphorylation level(For 48 hours after administration)