NCT02537938已完成1 期
A Randomized, Placebo-Controlled, Double-blind, Parallel-Group, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered NGP 555 in Healthy Subjects
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
- 24
- 试验地点
- 1
- 主要终点
- Number of adverse events or safety outcomes
研究概览
简要总结
This study involves the use of an investigational drug called NGP 555. In each group of healthy subjects, 2 people will receive placebo and 6 people will receive NGP 555.
详细描述
The purpose of this research study is to determine the safety, tolerability, and pharmacokinetics (PK) of multiple (14 days), oral doses of NGP 555 in healthy volunteers.
NGP 555 has been created for the treatment of Alzheimer's disease (AD). NGP 555 is being developed to prevent Abeta 42 amyloid formation, a protein that is likely a key factor in the development of AD.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers aged 40-65 yrs and in good health as determined by medical history, physical examination, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and investigator judgement
- •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 post-menopausal or surgically sterile
- •Female volunteers who are of child-bearing potential must agree to use a medically acceptable method of contraception
- •Male healthy volunteers willing to use barrier contraception (i.e., condoms) even if their partners are post-menopausal, surgically sterile or are using acceptable contraceptive methods
- •Body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 32.0 kg/m2
排除标准
- •Personal 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
- •Volunteer has 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, 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 >1.3 abnormal ranges of serum creatinine
- •Abnormal blood pressure
- •Abnormal cardiovascular parameters
- •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
- •Any suicidal behavior in the last 2 years
- •Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test
- •Volunteers unwilling to avoid consumption of coffee and caffeine containing beverages
- •Unable to abstain from smoking (or other nicotine use)
- •Donation of blood (> 500 mL) or blood products within 2 months
- •Volunteers who take prohibited medications
- •Use of an investigational drug within 30 days prior to Screening (Visit 1)
- •Unwilling to abstain from vigorous exercise
- •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
- •Volunteer is unlikely to comply with the protocol requirements, instructions and study-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visit and improbability of completing the clinical study)
- •Volunteer has medical conditions that are unstable or which, in the clinical opinion of the Investigator, may interfere with study procedures or volunteer safety. Volunteers with the following stable medical conditions, adequately controlled with stable doses of concomitant medications, need not be excluded if in the opinion of the Investigator, their conditions do not compromise volunteer safety or study procedures:
研究组 & 干预措施
NGP 555
Experimental
NGP 555 given once a day for 14 days as a capsule; 100 mg, 200 mg, or 400 mg
干预措施: NGP 555 (Drug)
结局指标
主要结局
Number of adverse events or safety outcomes
时间窗: Baseline to 23 days
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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