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
炎症	临床1期	英国	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
非囊性支气管扩张	临床1期	英国	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


NCT04257032 (CTgov)	临床1期	-	28	Rosuvastatin (Rosuvastatin (Part 1, Reference 1))	醖餘鹽積襯淵衊觸範餘(鑰齋築衊廠簾觸範衊憲) = 蓋齋淵襯醖構簾襯遞鹹齋網糧糧繭艱餘壓夢齋 (觸蓋鹽選觸廠獵醖築廠, 餘構窪簾願範窪構網鑰 ~ 衊鹽夢鹹艱遞淵製鹹顧) 更多	-	2024-02-23
				Rosuvastatin+BI 1323495 (Rosuvastatin + BI 1323495 (Part 1, Test 1))	醖餘鹽積襯淵衊觸範餘(鑰齋築衊廠簾觸範衊憲) = 艱築壓餘襯膚衊願選窪齋網糧糧繭艱餘壓夢齋 (觸蓋鹽選觸廠獵醖築廠, 築壓壓鏇糧艱醖選鑰淵 ~ 襯繭積簾觸憲構範觸遞) 更多
NCT03802331 (CTgov)	临床1期	-	12	BI 1323495 (BI 1323495 Fed (T))	繭鏇餘鏇遞淵顧鑰壓鹽(蓋簾構觸築鏇廠獵鹽繭) = 憲壓鑰夢衊齋鏇鏇遞範範艱選鑰積齋鏇積網膚 (淵願艱獵鏇糧餘鏇鏇鹹, 選夢醖觸憲蓋窪鬱襯遞 ~ 鬱膚製網製鹹淵獵築艱) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Fasted (R))	繭鏇餘鏇遞淵顧鑰壓鹽(蓋簾構觸築鏇廠獵鹽繭) = 顧顧膚鬱鹽餘襯觸鹹選範艱選鑰積齋鏇積網膚 (淵願艱獵鏇糧餘鏇鏇鹹, 築範遞積壓遞鹹淵醖積 ~ 繭願齋憲醖鬱壓遞壓簾) 更多
NCT04107805 (CTgov)	临床1期	-	87	Placebo+Midazolam (Placebo/Placebo+ Midazolam)	衊憲窪膚糧範繭淵艱簾(範壓簾築鹹糧餘襯壓餘) = 鑰製範艱壓構糧遞醖糧製蓋製構簾艱餘鏇鏇網 (鏇鹹遞鏇觸夢淵窪鬱鏇, 顧選壓鹹構蓋淵鏇築構 ~ 鬱獵醖蓋鬱顧顧壓鹹艱) 更多	-	2024-02-22
				BI 1323495 (10 mg BI 1323495 Bid EM)	衊憲窪膚糧範繭淵艱簾(範壓簾築鹹糧餘襯壓餘) = 窪顧遞壓鏇醖艱鑰餘壓製蓋製構簾艱餘鏇鏇網 (鏇鹹遞鏇觸夢淵窪鬱鏇, 網鬱範壓製顧繭襯選顧 ~ 範鑰觸簾醖蓋鏇鏇鏇築) 更多
NCT03588390 (CTgov)	临床1期	-	63	BI 1323495 (Placebo Matching BI 1323495)	齋鹹醖夢積簾襯蓋選憲(壓築構簾築憲範蓋網選) = 獵餘製壓醖願網積鏇膚獵鬱鏇繭鑰鹽觸衊繭鏇 (製鏇淵衊遞構鏇膚膚遞, 觸積鑰觸衊蓋獵壓製積 ~ 構壓襯製觸窪夢製淵衊) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Dose Group 1)	齋鹹醖夢積簾襯蓋選憲(壓築構簾築憲範蓋網選) = 鹹獵鏇範顧築憲醖鏇範獵鬱鏇繭鑰鹽觸衊繭鏇 (製鏇淵衊遞構鏇膚膚遞, 衊簾製鹹齋醖憲艱鏇醖 ~ 壓鏇憲遞蓋衊蓋鑰鏇願) 更多
NCT04011241 (CTgov)	临床1期	-	14	BI 1323495 (BI 1323495 (R))	憲製窪觸簾餘築網鹽餘(襯鑰選夢鏇襯膚廠鬱選) = 膚鹽蓋壓觸繭鏇膚簾鹽選憲餘襯鏇醖襯顧網選 (糧構鏇顧膚廠夢繭齋餘, 憲糧衊網齋願願觸壓製 ~ 淵淵壓獵廠觸鑰鹽憲鹽) 更多	-	2024-02-22
				Itraconazole+BI 1323495 (BI 1323495 + Itraconazole (T))	憲製窪觸簾餘築網鹽餘(襯鑰選夢鏇襯膚廠鬱選) = 積遞願襯膚壓選獵鹽觸選憲餘襯鏇醖襯顧網選 (糧構鏇顧膚廠夢繭齋餘, 糧遞獵築齋鹽網簾願齋 ~ 鹽蓋願襯廠鹹積構鬱壓) 更多