A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Oral Administration of ASP7991 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs
研究概览
简要总结
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.
详细描述
This study consists of two parts. In Part 1, the study will begin as a single rising dose escalation design under randomized double-blind and fasting conditions. In each dose group, volunteers will be randomized to receive an oral administration of either active drug (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.
Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to volunteers under 2 conditions, fasting and fed, on 2-way crossover method.
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 44 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
Part-1 dose 1
干预措施: ASP7991 (Drug)
Part-1 dose 2
干预措施: ASP7991 (Drug)
Part-1 dose 3
干预措施: ASP7991 (Drug)
Part-1 dose 4
干预措施: ASP7991 (Drug)
Part-1 dose 5
干预措施: ASP7991 (Drug)
Part-1 dose 6
干预措施: ASP7991 (Drug)
Part-1 placebo
干预措施: Placebo (Drug)
Part-2 fed
干预措施: ASP7991 (Drug)
Part-2 fasted
干预措施: ASP7991 (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 and Holter ECGs
时间窗: for 96 hours after dosing
次要结局
- Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F(for 96 hours after dosing)
- Urinary concentrations of unchanged drug: Aelast，Aelast%, CLr(for 96 hour after dosing)
- plasma parathyroid hormon concentration(for 96 hours after dosing)