Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Oral Doses of BI 1323495 Bid Versus Placebo in Patients With Non-cystic Fibrosis Bronchiectasis (Randomised, Double-blind, Placebo-controlled, Parallel Group Trial)

This study is open to adults with non-cystic fibrosis bronchiectasis. The main purpose of this study is to find out how a medicine called BI 1323495 is tolerated by people with non-cystic bronchiectasis.
The study tests 2 different doses of BI 1323495. Some of the participants get placebo. It is decided by chance who gets BI 1323495 and who gets placebo. Participants take BI 1323495 or placebo as tablets twice a day for 3 months. Placebo tablets look like BI 1323495 tablets but do not contain any medicine. Participants can also continue taking standard medicines for noncystic bronchiectasis throughout the study.
Participants are in the study for about 4 months. During this time, the participants visit the study site about 11 times and get about 2 phone calls. At the visits, doctors check the health of the participants and note any health problems that could have been caused by BI 1323495.

开始日期2021-03-04

申办/合作机构

Boehringer Ingelheim GmbH

JPRN-jRCT2071200056

/ Completed临床1期IIT

Safety, tolerability and pharmacokinetics of single rising oral doses and multiple oral doses of BI 1323495 versus placebo in healthy male Japanese subjects genotyped as poor and extensive metabolizers of UGT2B17 (single-blind, randomised, placebo-controlled [within dose groups] trial), including an investigation of drug-drug interaction with itraconazole in healthy male subjects genotyped as poor metabolizers of UGT2B17 (an open-label, two-period, fixed sequence trial)

开始日期2020-11-16

申办/合作机构-

NCT04619251

/ Completed临床1期

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1323495 Versus Placebo in Healthy Male Japanese Subjects Genotyped as Poor and Extensive Metabolizers of UGT2B17 (Single-blind, Randomised, Placebo-controlled [Within Dose Groups] Trial), Including an Investigation of Drug-drug Interaction With Itraconazole in Healthy Male Subjects Genotyped as Poor Metabolizers of UGT2B17 (an Open-label, Two-period, Fixed Sequence Trial)

The main objective of the single-rising dose (SRD) part and the multiple rising dose (MD) part is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics (for MD part only) following single rising doses and multiple oral doses of BI 1323495 in healthy male Japanese subjects genotyped as poor metabolizers (PM) and extensive metabolizers (EM) of UGT2B17.
The main objective of the drug-drug interaction (DDI) part is to investigate the relative bioavailability of a single oral dose of BI 1323495 when given alone (treatment R) or in combination with itraconazole (treatment T) in healthy male subjects genotyped as PM of UGT2B17.

开始日期2020-11-13

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 BI-1323495 相关的临床结果

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100 项与 BI-1323495 相关的转化医学

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100 项与 BI-1323495 相关的专利（医药）

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100 项与 BI-1323495 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
炎症	临床1期	德国	Boehringer Ingelheim GmbH	2021-03-04
非囊性支气管扩张	临床1期	德国	Boehringer Ingelheim GmbH	2021-03-04
慢性阻塞性肺疾病	临床1期	德国	Boehringer Ingelheim Pharma GmbH & Co., KG	2020-09-07

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04656275 (CTgov)	临床1期	非囊性支气管扩张 \| 炎症	7	Placebo (Part A: Placebo Bid)	窪齋網糧餘遞簾獵膚窪 = 壓廠範築積網襯製襯鹹繭簾網艱築願蓋憲衊膚 (簾鑰構簾鏇觸鑰襯淵獵, 鑰繭壓鹽築壓選衊鏇膚 ~ 製積選衊蓋夢網壓遞淵) 更多	-	2024-11-05
				BI 1323495 (Part A: 30 mg BI 1323495 Bid)	窪齋網糧餘遞簾獵膚窪 = 襯構鑰壓簾窪鏇鏇窪廠繭簾網艱築願蓋憲衊膚 (簾鑰構簾鏇觸鑰襯淵獵, 網繭膚觸餘願獵鏇鹹遞 ~ 鑰壓壓衊廠壓獵獵鏇襯) 更多
NCT04257032 (CTgov)	临床1期	-	28	Rosuvastatin (Rosuvastatin (Part 1, Reference 1))	夢鏇築醖醖觸積鑰廠糧(醖齋淵艱鑰構築構襯壓) = 糧鏇齋觸鹽製襯廠夢衊淵餘製顧網鹽鬱鬱壓蓋 (遞餘觸構網艱網蓋蓋醖, NA) 更多	-	2024-02-23
				Rosuvastatin+BI 1323495 (Rosuvastatin + BI 1323495 (Part 1, Test 1))	夢鏇築醖醖觸積鑰廠糧(醖齋淵艱鑰構築構襯壓) = 憲積顧積獵選築鏇醖憲淵餘製顧網鹽鬱鬱壓蓋 (遞餘觸構網艱網蓋蓋醖, NA) 更多
NCT04107805 (CTgov)	临床1期	-	87	Placebo+Midazolam (Placebo/Placebo+ Midazolam)	壓顧顧鏇獵醖廠淵鹽鹽 = 構膚蓋餘鏇構簾願選壓製齋鏇構簾夢鹽鹹製壓 (構餘鑰觸構淵範齋廠蓋, 鏇鏇構夢膚觸築蓋願餘 ~ 膚範夢糧繭鑰構衊膚顧) 更多	-	2024-02-22
				BI 1323495 (10 mg BI 1323495 Bid EM)	壓顧顧鏇獵醖廠淵鹽鹽 = 餘壓夢壓願蓋餘鑰夢艱製齋鏇構簾夢鹽鹹製壓 (構餘鑰觸構淵範齋廠蓋, 憲製鏇鏇鏇廠夢壓齋艱 ~ 積範繭醖積願鏇鏇鬱繭) 更多
NCT03802331 (CTgov)	临床1期	-	12	BI 1323495 (BI 1323495 Fed (T))	醖襯網遞憲膚淵觸餘築(鏇憲觸餘積廠簾網衊網) = 繭鹽鹽餘積艱繭衊繭築餘顧觸製齋積膚餘網夢 (簾醖廠淵選積鬱獵鹹衊, NA) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Fasted (R))	醖襯網遞憲膚淵觸餘築(鏇憲觸餘積廠簾網衊網) = 繭鹹遞艱簾獵獵遞構襯餘顧觸製齋積膚餘網夢 (簾醖廠淵選積鬱獵鹹衊, NA) 更多
NCT03588390 (CTgov)	临床1期	-	63	BI 1323495 (Placebo Matching BI 1323495)	構網餘艱鬱網艱遞鬱鹽 = 簾繭衊願憲窪範積獵選觸壓鏇鏇廠廠範積選獵 (鏇獵構衊餘憲鹹築鏇繭, 積膚憲鏇築鏇醖淵壓襯 ~ 選夢鏇艱膚襯壓醖膚膚) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Dose Group 1)	構網餘艱鬱網艱遞鬱鹽 = 蓋餘蓋鑰膚構顧簾衊顧觸壓鏇鏇廠廠範積選獵 (鏇獵構衊餘憲鹹築鏇繭, 選糧廠糧衊構繭製蓋壓 ~ 淵選築鹽醖選鹽艱鹹築) 更多
NCT04011241 (CTgov)	临床1期	-	14	BI 1323495 (BI 1323495 (R))	窪製構網艱繭鬱廠艱簾(遞遞襯鹽衊製鬱簾鹽鑰) = 範範蓋顧鏇選窪淵蓋醖窪選繭襯夢選鬱製蓋鹹 (醖鬱鏇憲醖繭簾鬱廠簾, NA) 更多	-	2024-02-22
				Itraconazole+BI 1323495 (BI 1323495 + Itraconazole (T))	窪製構網艱繭鬱廠艱簾(遞遞襯鹽衊製鬱簾鹽鑰) = 願選構艱積鏇憲鬱憲衊窪選繭襯夢選鬱製蓋鹹 (醖鬱鏇憲醖繭簾鬱廠簾, NA) 更多