A Phase 1, Randomized, Subject- and Investigator-blinded, Sponsor-unblinded, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of ASP7962, Including a Food-effect Evaluation in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety assessed by: clinical laboratory tests, vital signs, Electrocardiogram (ECG), Adverse Events (AEs), real time and continuous cardiac monitoring, orthostatic challenge test, and C-SSRS
研究概览
简要总结
The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject has a body mass index (BMI) range of 18.5 - 30.0 kg/m2, inclusive. The subject weighs at least 50 kg. [screening]
- •Female subject must be of non-childbearing potential:postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).
- •Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the clinical study period and for 90 days after the final study drug administration.
- •Male subject must not donate sperm starting at screening and throughout the clinical study period and for 90 days after the final study drug administration.
- •Subject agrees not to participate in another interventional study while in this clinical study.
排除标准
- •Subject has a known or suspected hypersensitivity to ASP7962 or any components of the formulation used.Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the Medical Investigator.
- •Subject has any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or on admission to the clinical unit on day -
- •Subject regularly uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit on day -
- •Subject had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission to the clinical unit on day -
- •Subject participated in any interventional clinical study or has been treated with any investigational drugs within 90 days or 5 half-lives whichever is longer, prior to the initiation of screening
- •Subject has a history of suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 3 months (a level of 4 or 5 for any 1 item on the scale), or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS at screening and on admission to the clinical unit on day -1.
研究组 & 干预措施
Placebo
Each dose level group will include 8 subjects, of which 2 will be randomized to receive placebo
干预措施: Placebo (Drug)
ASP7962
Each dose level group will include 8 subjects, of which 6 will be randomized to receive active ASP7962
干预措施: ASP7962 (Drug)
结局指标
主要结局
Safety assessed by: clinical laboratory tests, vital signs, Electrocardiogram (ECG), Adverse Events (AEs), real time and continuous cardiac monitoring, orthostatic challenge test, and C-SSRS
时间窗: Day -1 through End of Study Visit (7 to 14 days after (early) discharge from the clinical unit (only after the second treatment period for subjects required to return for the food-effect part of the clinical study))
Day 1 to End of Study Visit: Routine clinical laboratory tests (hematology, biochemistry \[additionally including testosterone, luteinizing hormone {LH}, follicle-stimulating hormone {FSH}, inhibin b, sex hormone-binding globulin {SHBG}\] and urinalysis), Vital Signs, ECG, A Es Day 1: Real-time cardiac monitoring Day 1 to Day 2: Continuous cardiac monitoring and orthostatic challenge test Day -1 and End of Study Visit: C-SSRS for suicidality risk
次要结局
- Pharmacokinetics of ASP7962 in plasma and urine(Day 1 to Day 7)