NCT01013610已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Multiple, Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNK 754 in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease
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
- 110
- 试验地点
- 7
- 主要终点
- Safety assessments to include pharmacokinetics, and adverse events
研究概览
简要总结
To evaluate the safety, tolerability, multiple dose plasma pharmacokinetics (PK) of LNK-754 in male and female elderly volunteers after dosing with LNK-754 for 7 days and in subjects with mild Alzheimer's Disease after dosing with LNK-754 for 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A and Part B:
- •Males or females aged 60 years or older. Females must be surgically sterilized or postmenopausal for at least two years. Males must be actively practicing double-barrier contraception (condom plus spermicide), unless they have had a vasectomy, or their partner(s) meet the above criteria for females.
- •Voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
- •Be prepared to adhere to the protocol requirements and be willing and able to remain in the study unit for the entire duration of the confinement period. They must also be willing to return for the End-of-Study Visit one week after the last dosing.
- •Part A only:
- •Subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinical deviations from normal limits in medical history, physical examination, vital sign measurements, ECG, or laboratory test results that are associated with stable, well controlled chronic illness. Subjects with concomitant diseases or using concomitant medication will be allowed to participate provided a stable condition and stable treatment for 1 month (30 days) prior to administration of the first dose of study medication. Inclusion of each subject will be reviewed with the Link Medical Monitor prior to enrollment in the trial.
- •Part B only:
- •Subjects with Mild Alzheimer's Disease, as defined by DSM-IV.
- •Subjects with a score of ≥ 18-26 on the Mini-Mental State Examination (MMSE).
- •Subjects with a Clinical Dementia Rating (CDR) total score of 0.5 or 1.0 (possible or mild dementia).
- •Subjects with a Rosen-Modified Hachinski Ischemic score of ≤ 4.
排除标准
- •Part A and Part B:
- •Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease, as determined by medical history, physical examination or laboratory tests.
- •Subjects who have positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- •Subjects who have received any experimental drugs or devices within 30 days prior to dosing or who wish to receive any experimental drug within 30 days after completing the study.
- •Subjects 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
Multiple Dose
Active Comparator
干预措施: LNK-754 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessments to include pharmacokinetics, and adverse events
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (7)
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