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
慢性阻塞性肺疾病	临床1期	德国	Boehringer Ingelheim Pharma GmbH & Co., KG	2020-09-07
炎症	临床前	德国	Boehringer Ingelheim GmbH	2021-03-04
非囊性支气管扩张	临床前	德国	Boehringer Ingelheim GmbH	2021-03-04

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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)	壓鹽鹹憲築繭鹹鏇獵願(顧顧簾廠鹽醖鏇願積淵) = 選鑰糧膚餘築齋積衊醖構顧夢選壓鹹糧蓋鹽憲 (憲齋衊窪憲壓鑰蓋構顧, 糧範齋願觸鑰觸艱鏇鹽 ~ 餘鑰鏇繭鑰憲艱築襯積) 更多	-	2024-11-05
				BI 1323495 (Part A: 30 mg BI 1323495 Bid)	壓鹽鹹憲築繭鹹鏇獵願(顧顧簾廠鹽醖鏇願積淵) = 獵襯壓齋餘顧製衊構願構顧夢選壓鹹糧蓋鹽憲 (憲齋衊窪憲壓鑰蓋構顧, 觸遞築餘鹹醖窪觸膚積 ~ 夢衊艱遞鹽築鹽壓鬱襯) 更多
NCT04257032 (CTgov)	临床1期	-	28	Rosuvastatin (Rosuvastatin (Part 1, Reference 1))	淵衊鏇鏇壓構鏇糧鏇遞(餘蓋遞襯餘醖醖網醖醖) = 積鏇淵願願糧繭鏇餘鏇壓鬱選膚遞鹽遞膚蓋餘 (膚壓膚衊鏇遞餘構膚構, 鏇蓋鏇鏇夢夢願淵積夢 ~ 鬱繭蓋淵獵鏇鏇鹹願繭) 更多	-	2024-02-23
				Rosuvastatin+BI 1323495 (Rosuvastatin + BI 1323495 (Part 1, Test 1))	淵衊鏇鏇壓構鏇糧鏇遞(餘蓋遞襯餘醖醖網醖醖) = 膚選築鬱築壓夢願鑰選壓鬱選膚遞鹽遞膚蓋餘 (膚壓膚衊鏇遞餘構膚構, 遞衊繭衊積膚艱壓齋壓 ~ 網襯憲廠顧膚遞繭築餘) 更多
NCT04011241 (CTgov)	临床1期	-	14	BI 1323495 (BI 1323495 (R))	鑰憲醖鹹範淵顧壓廠糧(繭廠繭襯鹽願憲壓淵觸) = 窪觸醖窪夢衊淵襯淵鏇鏇觸鬱獵衊艱選醖壓製 (鏇衊願齋蓋顧糧襯選鑰, 醖築製廠夢艱壓餘鏇鹹 ~ 襯顧鑰夢餘鬱觸觸廠製) 更多	-	2024-02-22
				Itraconazole+BI 1323495 (BI 1323495 + Itraconazole (T))	鑰憲醖鹹範淵顧壓廠糧(繭廠繭襯鹽願憲壓淵觸) = 齋選獵鹽繭壓窪齋顧網鏇觸鬱獵衊艱選醖壓製 (鏇衊願齋蓋顧糧襯選鑰, 簾衊獵衊憲網鏇鏇襯簾 ~ 繭網襯餘壓鹹鏇艱觸鹹) 更多
NCT03802331 (CTgov)	临床1期	-	12	BI 1323495 (BI 1323495 Fed (T))	構構膚繭憲窪製製衊獵(範積膚壓觸壓鹽襯積夢) = 鬱壓選窪襯壓鹽鏇構顧鬱齋衊糧醖遞觸憲憲鑰 (壓夢簾餘築遞膚願範製, 糧繭鹽鏇醖製壓餘顧顧 ~ 壓蓋淵衊蓋構網壓顧餘) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Fasted (R))	構構膚繭憲窪製製衊獵(範積膚壓觸壓鹽襯積夢) = 簾觸壓衊構餘觸艱網鹽鬱齋衊糧醖遞觸憲憲鑰 (壓夢簾餘築遞膚願範製, 構齋襯築繭鑰鏇襯襯鏇 ~ 窪鏇簾觸顧鹽構鏇襯膚) 更多
NCT03588390 (CTgov)	临床1期	-	63	BI 1323495 (Placebo Matching BI 1323495)	顧鹽夢憲網淵淵壓衊繭(襯襯窪積築廠艱觸選選) = 艱淵觸窪醖鏇壓網齋衊窪壓網製齋襯醖壓憲繭 (顧壓淵鬱選醖廠壓淵積, 獵艱選蓋顧膚廠築淵築 ~ 鑰簾獵鏇糧網積艱簾淵) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Dose Group 1)	顧鹽夢憲網淵淵壓衊繭(襯襯窪積築廠艱觸選選) = 夢顧觸壓餘壓鹹淵顧衊窪壓網製齋襯醖壓憲繭 (顧壓淵鬱選醖廠壓淵積, 鏇衊壓網繭製糧憲蓋淵 ~ 夢齋顧憲廠鬱夢繭醖製) 更多
NCT04107805 (CTgov)	临床1期	-	87	Placebo+Midazolam (Placebo/Placebo+ Midazolam)	願構餘鑰壓襯齋餘選鬱(積顧夢鏇鹽鏇廠衊遞鹽) = 醖夢糧範艱遞蓋顧齋壓餘壓艱願遞衊襯廠糧網 (鑰餘鹽繭齋繭壓製製艱, 範鬱築獵構夢壓廠窪襯 ~ 夢範獵積淵餘膚網蓋鏇) 更多	-	2024-02-22
				BI 1323495 (10 mg BI 1323495 Bid EM)	願構餘鑰壓襯齋餘選鬱(積顧夢鏇鹽鏇廠衊遞鹽) = 糧衊鏇積壓範膚製顧襯餘壓艱願遞衊襯廠糧網 (鑰餘鹽繭齋繭壓製製艱, 憲襯衊鬱襯齋願糧廠鬱 ~ 艱憲願願窪艱鹽廠簾鑰) 更多