NCT02642614已完成1 期
A Phase I Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of BI 1026706 Administered Orally as Tablets Twice Daily for 4 Weeks to Patients With COPD in Order to Evaluate Safety, Tolerability, Pharmacokinetics and Effect on Inflammation
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
- 120
- 试验地点
- 10
- 主要终点
- Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period.
研究概览
简要总结
The main objective of the current trial is to investigate safety, tolerability, pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4 weeks in patients with COPD.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 1026706 high dose
Experimental
干预措施: BI 1026706 (Drug)
BI 1026706 low dose
Experimental
干预措施: BI 1026706 (Drug)
BI 1026706 low dose
Experimental
干预措施: Placebo (Drug)
BI 1026706 medium
Experimental
干预措施: BI 1026706 (Drug)
BI 1026706 medium
Experimental
干预措施: Placebo (Drug)
BI 1026706 high dose
Experimental
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period.
时间窗: From first drug administration until 4 days after last drug administration, up to 32 days
Safety and tolerability of BI 1026706, as assessed by frequency (in percent) of patients with treatment-emergent adverse events (TEAEs) over the treatment period.
次要结局
- Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax, ss) After the Last Dose (Morning of Day 28)(-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.)
- Change in Absolute Number of Neutrophil in Sputum at the End of the Planned Treatment Period(28 days)
- Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax) After the First Dose (Morning of Day 1)(-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.)
- Area Under the Concentration-time Curve of BI 1026706 in Plasma (AUC 0-12h) After the First Dose (Morning of Day 1)(-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.)
- Maximum Measured Concentration of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax, ss) After the Last Dose (Morning of Day 28)(-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.)
- Maximum Measured Concentration of BI 1026706 in Plasma (Cmax) After the First Dose (Morning of Day 1)(-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.)
- Area Under the Concentration-time Curve of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUC Tau, ss) After the Last Dose (Morning of Day 28)(-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.)
研究者
研究点 (10)
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