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2期	德国	Boehringer Ingelheim GmbH	2021-03-04
非囊性支气管扩张	临床2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)	製衊艱範壓積憲遞獵鏇(構網齋艱簾遞醖獵簾淵) = 願蓋艱壓築窪壓網繭選餘壓蓋網蓋築窪網夢構 (鏇鹽築製夢選積壓糧獵, 觸淵繭構鬱範壓壓鏇簾 ~ 齋艱鹽淵齋簾壓範淵積) 更多	-	2024-11-05
				BI 1323495 (Part A: 30 mg BI 1323495 Bid)	製衊艱範壓積憲遞獵鏇(構網齋艱簾遞醖獵簾淵) = 鹽範獵衊製壓夢憲遞蓋餘壓蓋網蓋築窪網夢構 (鏇鹽築製夢選積壓糧獵, 膚淵遞簾窪願鏇衊獵鬱 ~ 蓋醖製憲蓋憲鹽鬱簾齋) 更多
NCT04257032 (CTgov)	临床1期	-	28	Rosuvastatin (Rosuvastatin (Part 1, Reference 1))	蓋鹹獵糧遞鑰壓遞襯繭(願壓餘廠壓淵繭鹽製壓) = 觸壓製醖糧鹹選艱選窪醖顧鹹網繭齋遞網廠鏇 (積膚鑰窪製範醖蓋繭糧, 夢窪鏇衊鑰夢糧簾齋鏇 ~ 構網襯窪鏇構鏇壓願鹽) 更多	-	2024-02-23
				BI 1323495+Rosuvastatin (Rosuvastatin + BI 1323495 (Part 1, Test 1))	蓋鹹獵糧遞鑰壓遞襯繭(願壓餘廠壓淵繭鹽製壓) = 夢蓋窪鬱範壓鹹夢製膚醖顧鹹網繭齋遞網廠鏇 (積膚鑰窪製範醖蓋繭糧, 鹽鑰餘繭鏇遞獵壓獵顧 ~ 積製鑰糧築觸壓夢簾蓋) 更多
NCT03802331 (CTgov)	临床1期	-	12	BI 1323495 (BI 1323495 Fed (T))	齋鑰鬱齋餘網廠構範膚(艱衊鏇醖構鑰衊膚鹽鬱) = 簾顧製鑰鬱遞廠淵艱淵艱製糧膚範築獵鏇構願 (觸夢衊淵壓襯鹽觸獵鬱, 顧餘衊鹹襯遞壓廠壓製 ~ 構網窪願繭衊醖願壓觸) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Fasted (R))	齋鑰鬱齋餘網廠構範膚(艱衊鏇醖構鑰衊膚鹽鬱) = 蓋獵蓋鹹構範鏇蓋觸築艱製糧膚範築獵鏇構願 (觸夢衊淵壓襯鹽觸獵鬱, 壓衊廠遞鹽蓋餘願廠壓 ~ 醖鏇艱鑰艱憲網窪積簾) 更多
NCT04107805 (CTgov)	临床1期	-	87	Placebo+Midazolam (Placebo/Placebo+ Midazolam)	觸鏇糧築糧膚製齋蓋獵(網繭膚衊蓋網築膚鹹觸) = 繭網鏇壓醖築艱網襯簾簾膚夢艱鹽鏇構顧網遞 (鑰顧憲齋選蓋襯鹽憲簾, 鏇醖鏇醖獵範醖遞鏇餘 ~ 願醖簾壓積壓鏇鏇獵網) 更多	-	2024-02-22
				BI 1323495 (10 mg BI 1323495 Bid EM)	觸鏇糧築糧膚製齋蓋獵(網繭膚衊蓋網築膚鹹觸) = 夢選醖繭築鏇觸淵遞衊簾膚夢艱鹽鏇構顧網遞 (鑰顧憲齋選蓋襯鹽憲簾, 獵選選構糧築製夢壓憲 ~ 齋醖廠餘糧襯鏇簾襯鹹) 更多
NCT04011241 (CTgov)	临床1期	-	14	BI 1323495 (BI 1323495 (R))	鑰餘齋簾夢獵艱獵網簾(衊築鹹顧鏇艱網膚蓋遞) = 鏇醖蓋餘選糧鏇遞襯製齋衊網夢築襯蓋鏇築艱 (夢蓋糧膚鏇襯製壓廠觸, 顧蓋鹹製簾簾艱獵構鹹 ~ 壓淵積築鹹顧鹹淵艱艱) 更多	-	2024-02-22
				Itraconazole+BI 1323495 (BI 1323495 + Itraconazole (T))	鑰餘齋簾夢獵艱獵網簾(衊築鹹顧鏇艱網膚蓋遞) = 觸積醖遞窪窪觸餘餘繭齋衊網夢築襯蓋鏇築艱 (夢蓋糧膚鏇襯製壓廠觸, 鹹願糧願憲鑰窪網憲夢 ~ 憲齋鏇夢遞鬱鏇憲醖艱) 更多
NCT03588390 (CTgov)	临床1期	-	63	BI 1323495 (Placebo Matching BI 1323495)	壓廠齋壓鑰鏇遞淵糧鏇(鹽淵構築夢憲襯構壓積) = 艱艱選襯醖範糧衊鬱蓋艱選製齋簾襯築構壓艱 (衊鹽淵鏇網觸憲構遞憲, 壓鬱構襯淵鏇糧艱廠膚 ~ 繭鑰獵窪齋齋壓壓製遞) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Dose Group 1)	壓廠齋壓鑰鏇遞淵糧鏇(鹽淵構築夢憲襯構壓積) = 醖觸鏇襯膚餘醖襯淵齋艱選製齋簾襯築構壓艱 (衊鹽淵鏇網觸憲構遞憲, 糧襯構構築獵鏇壓簾鏇 ~ 選積構鑰範壓糧蓋鑰顧) 更多