一项在特发性肺纤维化(IPF)患者中评价BI 1819479不同剂量口服给药至少24周的有效性、安全性和耐受性的随机、双盲、安慰剂对照、剂量探索研究
主要目的是使用BI 1819479三种不同口服剂量,基于最长52周治疗期间FVC的年下降率证明非平坦的剂量效应曲线,并评价定量治疗效应尺度和剂量-效应关系。 次要目的是通过比较BI 1819479三种不同剂量和安慰剂的FVC下降方面的差异(第24周FVC相对于基线的绝对变化)来评价有效性。 对次要和其他有效性及安全性参数的评估将进一步支持后续开发的剂量(范围)选择。
A Randomised, Double-blind, Placebo-controlled, Dose-finding Study Evaluating Efficacy, Safety, and Tolerability of Different Oral Doses of BI 1819479 Over at Least 24 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.
Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff.
At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.
The Effect of Multiple Doses of Esomeprazole on the Single-dose Pharmacokinetics of BI 1819479 Following Oral Administration in Healthy Male Subjects (an Open-label, Randomized, Two-way Cross-over Study)
The main objective of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of BI 1819479 in plasma.
100 项与 BI-1819479 相关的临床结果
100 项与 BI-1819479 相关的转化医学
100 项与 BI-1819479 相关的专利(医药)
100 项与 BI-1819479 相关的药物交易