Randomized, Double-blinded, Placebo-controlled, Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and slit lamp examination
研究概览
简要总结
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.
详细描述
In each step (lowest dose, middle dose, highest dose), subjects are randomly assigned in a double blinded manner to receive either ASP7991 (n=9) or Placebo (n=3) and are administered repeatedly. Once daily, the subjects are administered ASP7991 or placebo orally 30 minutes after breakfast with 150 mL water for 7 days. After the each step the sponsor evaluates the safety in the blinded manner for deciding an escalation to the step.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration
- •Body weight: ≥50.0 kg, <80.0 kg
- •BMI: ≥17.6, <26.4
- •Serum corrected calcium concentration: ≥9.0mg/dL, <10.4 mg/dL
排除标准
- •Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening
- •Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening
- •Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication
- •A deviation from normal criteria range of 12-lead ECG (QT evaluation)
- •A deviation from the normal range in clinical laboratory tests
- •Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL
- •History of drug allergies
- •Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission
- •Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury)
- •Concurrent or previous endocrine disorders (e.g., hyperthyroidism, aberration in growth hormone)
研究组 & 干预措施
low dose ASP7991
干预措施: ASP7991 (Drug)
middle dose ASP7991
干预措施: ASP7991 (Drug)
high dose ASP7991
干预措施: ASP7991 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and slit lamp examination
时间窗: For 96 hours after dosing
次要结局
- Plasma concentrations unchanged drug; AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F(For 96 hours after dosing)
- Urinary concentrations unchanged drug; Aelast, Aelast%, CLR(For 96 hours after dosing)