Pharmacokinetic and Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from time zero to 24 hours [(AUC(0-24h)]
研究概览
简要总结
The purpose of this study is to characterize emixustat hydrochloride pharmacokinetic and pharmacodynamic parameters in subjects with geographic atrophy associated with dry age-related macular degeneration.
详细描述
This is a multi-center, randomized, masked, multiple-dose, crossover study of the pharmacokinetics of emixustat hydrochloride (HCl) in subjects with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). Subjects will receive study drug during multiple dose periods in a crossover design, and serve as their own controls. There is a 21-28 day washout period between dose periods. The final Study Exit visit is 21 to 28 days after the subject's last dose of study drug at the end of the final dosing period.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age ≥65 years
- •Clinical diagnosis of GA associated with AMD
- •Able and willing to provide written informed consent
- •Able to reliably administer oral medication by self or with available assistance
排除标准
- •Geographic atrophy associated with a condition other than AMD
- •History of, active or high risk of developing choroidal neovascularization (CNV) in either eye
- •Known serious allergy to the fluorescein sodium for injection in angiography
- •Pre-specified laboratory abnormalities at screening
- •Treatment with any investigational study drug within 30 days of screening or device within 60 days of screening
- •Prior participation in any clinical study of emixustat
- •History of other disease, metabolic dysfunction, chronic immunosuppression, physical examination finding
- •Male subjects who are not surgically sterile and are not willing to practice a medically accepted method of birth control with their female partner of childbearing potential from screening through 21 days after the last dose of study drug
研究组 & 干预措施
Cohort 1
Two dose periods in any sequence (subjects will be assigned to 1 of 2 possible sequences):
- Emixustat HCl Tablet Strength B (mid dose); 1 tablet once daily & 1 placebo tablet once daily for 7 days
- Emixustat HCl Tablet Strength A (low dose); 1 tablet twice daily for 7 days
干预措施: Emixustat HCl Tablet (Drug)
Cohort 1
Two dose periods in any sequence (subjects will be assigned to 1 of 2 possible sequences):
- Emixustat HCl Tablet Strength B (mid dose); 1 tablet once daily & 1 placebo tablet once daily for 7 days
- Emixustat HCl Tablet Strength A (low dose); 1 tablet twice daily for 7 days
干预措施: Placebo Tablet (Other)
Cohort 2
Three dose periods in any sequence (subjects will be assigned to 1 of 6 possible sequences):
- Emixustat HCl Tablet Strength A (low dose); 1 tablet daily for 7 days
- Emixustat HCl Tablet Strength B (mid dose); 1 tablet daily for 7 days
- Emixustat HCl Tablet Strength C (high dose); 1 tablet daily for 7 days
干预措施: Emixustat HCl Tablet (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from time zero to 24 hours [(AUC(0-24h)]
时间窗: Day 1 and Day 7 of each dosing period
Degree of suppression of the ERG b-wave response post-photobleaching.
时间窗: Screening through Day 10 of each dosing period and study exit
次要结局
未报告次要终点