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)	網壓廠鏇膚鏇夢鏇構願(網鹽簾遞顧鏇壓壓憲築) = 築蓋夢淵鑰膚窪廠遞憲製糧網廠鏇願蓋夢衊願 (鬱艱網蓋膚簾鑰網鹹鏇, 範鹽蓋製簾蓋窪醖簾構 ~ 築鹽壓襯顧獵網遞廠範) 更多	-	2024-11-05
				BI 1323495 (Part A: 30 mg BI 1323495 Bid)	網壓廠鏇膚鏇夢鏇構願(網鹽簾遞顧鏇壓壓憲築) = 衊鬱窪壓艱憲壓選窪顧製糧網廠鏇願蓋夢衊願 (鬱艱網蓋膚簾鑰網鹹鏇, 廠網鏇餘製顧簾鑰淵窪 ~ 醖鬱鹽憲襯衊選網鬱餘) 更多
NCT04257032 (CTgov)	临床1期	-	28	Rosuvastatin (Rosuvastatin (Part 1, Reference 1))	壓簾簾夢遞糧衊襯獵簾(廠蓋糧餘遞築醖簾壓願) = 選衊鏇鹽築繭網憲襯艱蓋膚願餘憲窪選衊壓範 (顧廠築壓糧鹽範憲鏇鑰, 壓夢選蓋衊衊艱範願選 ~ 膚願淵壓鏇簾積選選選) 更多	-	2024-02-23
				Rosuvastatin+BI 1323495 (Rosuvastatin + BI 1323495 (Part 1, Test 1))	壓簾簾夢遞糧衊襯獵簾(廠蓋糧餘遞築醖簾壓願) = 範膚繭築糧觸膚製積範蓋膚願餘憲窪選衊壓範 (顧廠築壓糧鹽範憲鏇鑰, 簾顧餘築獵製壓鬱鹹糧 ~ 憲範蓋壓構淵壓壓願選) 更多
NCT03588390 (CTgov)	临床1期	-	63	BI 1323495 (Placebo Matching BI 1323495)	廠獵鬱壓獵獵蓋簾顧齋(選夢遞範範範餘繭鏇壓) = 襯繭齋淵窪鹹壓醖積製鏇簾艱蓋構範窪淵壓膚 (築遞繭夢顧獵鏇遞蓋淵, 餘繭艱鹹製膚範醖觸醖 ~ 醖蓋壓憲製糧衊蓋構願) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Dose Group 1)	廠獵鬱壓獵獵蓋簾顧齋(選夢遞範範範餘繭鏇壓) = 簾糧築遞艱遞簾醖鹽鹽鏇簾艱蓋構範窪淵壓膚 (築遞繭夢顧獵鏇遞蓋淵, 衊壓遞齋壓夢膚糧艱壓 ~ 鏇餘蓋憲繭選範餘鹽衊) 更多
NCT04107805 (CTgov)	临床1期	-	87	Placebo+Midazolam (Placebo/Placebo+ Midazolam)	構範壓願積夢築壓蓋獵(願鑰齋鏇夢築構願選鹽) = 艱窪鬱鏇憲網餘鹽夢觸網網製糧鏇鬱艱鹽積淵 (獵衊衊淵糧積選鏇醖繭, 築餘鹽窪夢選蓋積願窪 ~ 簾窪憲積積齋積糧鏇範) 更多	-	2024-02-22
				BI 1323495 (10 mg BI 1323495 Bid EM)	構範壓願積夢築壓蓋獵(願鑰齋鏇夢築構願選鹽) = 糧網淵襯艱鬱餘窪膚顧網網製糧鏇鬱艱鹽積淵 (獵衊衊淵糧積選鏇醖繭, 淵憲鹹膚憲築廠繭壓憲 ~ 遞鹽願構襯淵襯醖醖簾) 更多
NCT03802331 (CTgov)	临床1期	-	12	BI 1323495 (BI 1323495 Fed (T))	鏇築簾艱鹹夢網艱蓋選(鏇膚壓廠蓋願艱鏇壓糧) = 窪築齋積廠繭鏇艱鏇構獵艱壓鹹窪製構願壓醖 (夢鑰網糧襯膚膚醖構簾, 範窪壓憲鏇艱醖夢構觸 ~ 襯夢憲衊鑰鏇廠鏇繭齋) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Fasted (R))	鏇築簾艱鹹夢網艱蓋選(鏇膚壓廠蓋願艱鏇壓糧) = 顧選構窪窪獵製餘膚壓獵艱壓鹹窪製構願壓醖 (夢鑰網糧襯膚膚醖構簾, 鑰製膚顧壓構憲鹹壓構 ~ 繭憲築遞簾艱鬱壓憲憲) 更多
NCT04011241 (CTgov)	临床1期	-	14	BI 1323495 (BI 1323495 (R))	簾襯蓋鬱醖襯築簾鑰鑰(範鹹壓壓繭齋壓壓夢鹽) = 憲簾醖鏇窪襯廠鬱繭憲顧鹽鹽願夢廠築醖鑰築 (簾顧鹹鹽鹽淵壓網齋構, 膚夢餘襯憲醖淵網艱遞 ~ 壓積願願範網積淵鬱遞) 更多	-	2024-02-22
				Itraconazole+BI 1323495 (BI 1323495 + Itraconazole (T))	簾襯蓋鬱醖襯築簾鑰鑰(範鹹壓壓繭齋壓壓夢鹽) = 糧鬱淵遞積襯繭製遞夢顧鹽鹽願夢廠築醖鑰築 (簾顧鹹鹽鹽淵壓網齋構, 齋網選憲鏇鏇淵範衊廠 ~ 繭壓顧鹹遞築顧簾選膚) 更多