NCT02534480已完成1 期
A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered NGP 555 in Healthy Young Volunteers
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
- 40
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events as a measure of safety and tolerability
研究概览
简要总结
NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease amyloid buildup by targeting Abeta 42 production.
详细描述
NGP 555 is a gamma-secretase modulator with a selective mechanism to reduce Abeta 42 while raising shorter Abeta forms such as Abeta 37 and 38.
NGP 555 is being developed as a preventative disease modifying therapy for Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female volunteers aged 18-55 yrs and in good health as determined by medical history, physical examination, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and investigator judgment
- •Volunteer voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures
- •Female volunteers who are of child-bearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device.
- •Male healthy volunteers willing to use barrier contraception.
- •Body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2
排除标准
- •History of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (e.g., history of head trauma or concussion, previous alcohol abuse, substance abuse)
- •Any concurrent disease or condition that, in the opinion of the Investigator, would make the volunteer unsuitable for participation in the clinical study
- •History of alcohol and/or illicit drug abuse within two years of entry
- •Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, anxiety or delusions)
- •History of cerebrovascular events or non-vasovagal related loss of consciousness
- •History of cardiac arrhythmias, ischemic heart disease or cerebrovascular disease
- •Hepatic impairment as defined by >1.3 times the upper limit of normal ranges of serum liver enzymes
- •Renal impairment as defined by abnormal ranges of serum creatinine.
- •Presence of clinically significant orthostatic hypotension (fall in systolic blood pressure of >20 mmHg or fall diastolic blood pressure of > 10 mmHg; and increase in heart rate by > 20 beats per minute [bpm])
- •Corrected QT interval (QTc) values of > 450 ms for males and > 470 ms for females.
- •Volunteers with abnormally low serum B12, folate or abnormal thyroid function tests
- •Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
- •Positive urine test for alcohol or drugs
- •Suicidal ideation
- •Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test
- •Clinically significant deviation from normal in physical examination, vital signs or clinical laboratory tests
- •Volunteer is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study
研究组 & 干预措施
NGP 555 300 mg
Active Comparator
NGP 555 300 mg capsule and placebo by mouth once per day
干预措施: NGP 555 (Drug)
NGP 555 25 mg
Active Comparator
NGP 555 25 mg capsule and placebo by mouth once per day
干预措施: NGP 555 (Drug)
NGP 555 50 mg
Active Comparator
NGP 555 50 mg capsule and placebo by mouth once per day
干预措施: NGP 555 (Drug)
NGP 555 100 mg
Active Comparator
NGP 555 100 mg capsule and placebo by mouth once per day
干预措施: NGP 555 (Drug)
NGP 555 200 mg
Active Comparator
NGP 555 200 mg capsule and placebo by mouth once per day
干预措施: NGP 555 (Drug)
结局指标
主要结局
Number of subjects with adverse events as a measure of safety and tolerability
时间窗: 0-96 hours post-dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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