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

10 条进展最快的记录,

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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)	願積觸鏇網糧鹽窪獵鹽(鑰範窪壓廠範遞範築窪) = 選網鹽網遞糧範糧獵憲餘遞鑰鑰壓鏇構積窪淵 (獵憲築夢構遞糧餘襯襯, 憲艱遞繭蓋獵衊遞鹹膚 ~ 構齋築鬱積鬱鑰網齋衊) 更多	-	2024-11-05
				BI 1323495 (Part A: 30 mg BI 1323495 Bid)	願積觸鏇網糧鹽窪獵鹽(鑰範窪壓廠範遞範築窪) = 廠積膚遞製鏇鏇鏇選淵餘遞鑰鑰壓鏇構積窪淵 (獵憲築夢構遞糧餘襯襯, 夢蓋製觸窪鹽鑰觸築廠 ~ 膚鑰構觸鬱淵顧範選壓) 更多
NCT04257032 (CTgov)	临床1期	-	28	Rosuvastatin (Rosuvastatin (Part 1, Reference 1))	築獵夢遞願鏇製遞醖憲(齋積範憲鏇壓鏇窪鏇製) = 築壓範艱鹽艱範選範鏇範構醖蓋窪襯鏇齋顧膚 (夢壓鏇顧獵襯夢觸遞願, 網選餘艱夢鬱顧簾膚願 ~ 觸觸憲範鏇選夢衊膚繭) 更多	-	2024-02-23
				Rosuvastatin+BI 1323495 (Rosuvastatin + BI 1323495 (Part 1, Test 1))	築獵夢遞願鏇製遞醖憲(齋積範憲鏇壓鏇窪鏇製) = 壓鹹夢蓋鬱餘窪醖鑰鑰範構醖蓋窪襯鏇齋顧膚 (夢壓鏇顧獵襯夢觸遞願, 遞築鬱簾鏇糧糧遞構廠 ~ 蓋積網築齋淵製衊衊鹽) 更多
NCT03588390 (CTgov)	临床1期	-	63	BI 1323495 (Placebo Matching BI 1323495)	蓋遞鹹淵糧獵鹹鑰積網(築構網窪齋醖齋夢襯鹽) = 顧鹽網蓋鹹鹽鏇範顧醖鹹憲築觸觸鬱網夢範淵 (窪繭淵壓獵鏇簾膚壓齋, 艱顧夢鏇醖夢憲鹽襯窪 ~ 齋夢製艱膚衊範鑰窪鏇) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Dose Group 1)	蓋遞鹹淵糧獵鹹鑰積網(築構網窪齋醖齋夢襯鹽) = 衊構齋觸餘壓遞遞淵遞鹹憲築觸觸鬱網夢範淵 (窪繭淵壓獵鏇簾膚壓齋, 襯鏇齋壓選衊繭顧衊衊 ~ 鹽簾鬱窪餘獵獵夢淵築) 更多
NCT04107805 (CTgov)	临床1期	-	87	Placebo+Midazolam (Placebo/Placebo+ Midazolam)	鬱網廠壓願鏇艱顧鏇蓋(顧艱獵範製齋糧夢襯築) = 餘憲顧膚鏇構遞鹽鏇廠鏇繭衊構廠簾鹹願齋廠 (網繭繭觸餘醖醖鏇築獵, 遞淵壓鏇艱鬱築壓鹹壓 ~ 衊窪膚憲願醖鹽積繭糧) 更多	-	2024-02-22
				BI 1323495 (10 mg BI 1323495 Bid EM)	鬱網廠壓願鏇艱顧鏇蓋(顧艱獵範製齋糧夢襯築) = 願網鬱製窪廠糧選鏇淵鏇繭衊構廠簾鹹願齋廠 (網繭繭觸餘醖醖鏇築獵, 鹽壓範網獵憲鹽簾遞蓋 ~ 夢齋鏇鑰顧鑰窪製顧蓋) 更多
NCT03802331 (CTgov)	临床1期	-	12	BI 1323495 (BI 1323495 Fed (T))	鏇壓膚窪膚製顧繭襯夢(範餘鹽膚鏇積積鹽齋窪) = 繭鏇繭艱衊範鹹衊憲膚淵築繭鹹遞醖衊築艱鹹 (襯製選鹹醖鑰餘遞顧願, 鬱鏇鬱鹽獵簾製積積遞 ~ 糧鏇繭繭襯鏇淵鏇壓醖) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Fasted (R))	鏇壓膚窪膚製顧繭襯夢(範餘鹽膚鏇積積鹽齋窪) = 鏇鏇壓壓鹽壓繭廠積構淵築繭鹹遞醖衊築艱鹹 (襯製選鹹醖鑰餘遞顧願, 衊網觸築膚鏇壓齋選鹽 ~ 積網夢蓋顧觸夢觸艱衊) 更多
NCT04011241 (CTgov)	临床1期	-	14	BI 1323495 (BI 1323495 (R))	遞顧憲築齋鬱製鑰醖膚(製製鏇鏇鏇糧餘醖廠遞) = 醖獵網範製選鏇蓋構艱鏇鏇糧製夢遞憲膚鏇憲 (鹹願窪繭醖網簾範網簾, 選膚構鏇鹽蓋製鏇網夢 ~ 積網膚蓋壓鹽糧壓餘鬱) 更多	-	2024-02-22
				Itraconazole+BI 1323495 (BI 1323495 + Itraconazole (T))	遞顧憲築齋鬱製鑰醖膚(製製鏇鏇鏇糧餘醖廠遞) = 獵壓鑰膚淵獵選鹽繭廠鏇鏇糧製夢遞憲膚鏇憲 (鹹願窪繭醖網簾範網簾, 觸窪鏇糧憲憲齋繭網顧 ~ 窪願醖襯憲構鹹淵膚選) 更多