Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change From Baseline in Cerebral Blood Flow (CBF) at Day 15
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.
详细描述
Participants will receive up to a total of 30 daily doses of study drug (15 days of daily IW-6463, only; 15 days of daily placebo, only) administered across two 15-day dosing periods (Period 1 and Period 2). The dosing periods will be separated by a 27-day washout. Participants will be randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Subject is an ambulatory adult at least 65 years old at the screening visit
- •Subject is in good health and has no clinically significant findings on physical examination
- •Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state.
- •Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol
- •Men must also agree to not donate sperm throughout the study and for 3 months after the final dose of study drug
- •Other inclusion criteria per protocol
排除标准
- •Any active or unstable clinically significant medical condition
- •Other exclusion criteria per protocol
研究组 & 干预措施
IW-6463
IW-6463 tablets administered orally
干预措施: IW-6463 (Drug)
Placebo
Matching placebo tablets administered orally
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Change From Baseline in Cerebral Blood Flow (CBF) at Day 15
时间窗: Baseline, 15 days
Change from baseline in CBF as measured by magnetic resonance imaging (MRI) and arterial spin labeling (ASL) after administration of IW-6463 vs. placebo
Number of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 42 days
次要结局
未报告次要终点