NCT02078310已完成1 期
A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Escalation for Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia.
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
- 35
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy geriatric volunteers
- •MMSE score of >= 26 at screening
- •BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening
- •Geriatric patients with a clinical diagnosis of dementia
- •MMSE score of < 26 at screening
- •BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening
排除标准
- •Any clinically significant illness within 6 months before screening
- •Any history of cancer within last 5 years
- •History of Hepatitis B or C infection and elevated ALT, AST or bilirubin above the upper limit of normal level
- •Any subject considered to be an imminent danger to themselves or others
研究组 & 干预措施
ITI-007 Part 1
Experimental
Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007
干预措施: ITI-007 (Drug)
Placebo Part 1
Placebo Comparator
Part 1: Healthy geriatric volunteers with placebo given
干预措施: Placebo (Drug)
ITI-007 Part 2
Experimental
Part 2: Geriatric patients with dementia with ITI-007 given
干预措施: ITI-007 (Drug)
Placebo Part 2
Placebo Comparator
Part 2: Geriatric patients with dementia with placebo given
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: up to 7 days
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.
次要结局
- Area under the concentration-time curve (AUC)(pre-dose and multiple collection points up to 72 h after the last dose)
研究者
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