Randomised, Parallel-group, Double-blind Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Age-comparable Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- The Percentage of Participants With Adverse Events (AEs), Coded to the Medical Dictionary for Regulatory Activities - System Organ Class Eye Disorders, as Determined by the Investigator at the End of Trial
研究概览
简要总结
Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate the ocular and systemic safety and pharmacokinetics during 14 day treatment period in patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 409306 25 milligram (mg) - Alzheimer patients
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
干预措施: Placebo matching BI 409306 50 mg (Drug)
BI 409306 25 milligram (mg) - Alzheimer patients
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
干预措施: BI 409306 25 mg (Drug)
BI 409306 25 mg - Healthy volunteers
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
干预措施: Placebo matching BI 409306 50 mg (Drug)
BI 409306 100 mg - Alzheimer patients
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
干预措施: Placebo matching BI 409306 25 mg (Drug)
BI 409306 100 mg - Alzheimer patients
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
干预措施: BI 409306 50 mg (Drug)
BI 409306 25 mg - Schizophrenia patients
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
干预措施: Placebo matching BI 409306 50 mg (Drug)
BI 409306 25 mg - Schizophrenia patients
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
干预措施: BI 409306 25 mg (Drug)
BI 409306 100 mg - Schizophrenia patients
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
干预措施: Placebo matching BI 409306 25 mg (Drug)
BI 409306 100 mg - Schizophrenia patients
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
干预措施: BI 409306 50 mg (Drug)
BI 409306 25 mg - Healthy volunteers
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
干预措施: BI 409306 25 mg (Drug)
BI 409306 100 mg - Healthy volunteers
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
干预措施: Placebo matching BI 409306 25 mg (Drug)
BI 409306 100 mg - Healthy volunteers
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
干预措施: BI 409306 50 mg (Drug)
结局指标
主要结局
The Percentage of Participants With Adverse Events (AEs), Coded to the Medical Dictionary for Regulatory Activities - System Organ Class Eye Disorders, as Determined by the Investigator at the End of Trial
时间窗: From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The percentage of participants with Adverse Events (AEs), coded to the Medical Dictionary for Regulatory Activities (MedDRA) - System Organ Class (SOC) 'Eye disorders', as determined by the investigator at the End of Trial (EOT) is reported. Percentages were rounded to one decimal place.
次要结局
- Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)(Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.)
- The Percentage of Participants With Drug-related AEs as Determined by the Investigator at EOT(From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.)
- Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)(Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.)