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临床试验/NCT02254161
NCT02254161终止1 期

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 1181181 Given Orally q.d. for 10 Days in Young Healthy Male and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
36
试验地点
1
主要终点
frequency [N (%)] of subjects with drug-related adverse events

研究概览

简要总结

The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Matching placebo in healthy young

Placebo Comparator

Matching placebo for 10 days

干预措施: Matching placebo (Drug)

BI 1181181 healthy young

Experimental

Medium doses as tablets q.d. for 10 days

干预措施: BI 1181181 Healthy young (Drug)

BI 1181181 healthy elderly

Experimental

Medium doses as tablets q.d. for 10 days

干预措施: BI 1181181 healthy elderly (Drug)

Matching placebo in healthy elderly

Placebo Comparator

Matching placebo for 10 days

干预措施: Matching placebo (Drug)

结局指标

主要结局

frequency [N (%)] of subjects with drug-related adverse events

时间窗: days 1 to 24

次要结局

  • Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose(0 to 336 hours)
  • AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)(0 to 336 hours)
  • AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose(0 to 336 hours)
  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose(0 to 336 hours)
  • Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose(0 to 336 hours)
  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose(0 to 336 hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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