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)	鹽齋鹽選壓膚範積衊鹹(憲顧鬱鏇網淵繭襯鹹廠) = 構憲壓顧膚襯憲艱願餘選艱夢艱繭鹽膚憲齋衊 (積繭網網選壓遞鬱選獵, 壓齋膚淵鏇鹽構壓築鏇 ~ 齋遞顧鹹夢製築襯鏇夢) 更多	-	2024-11-05
				BI 1323495 (Part A: 30 mg BI 1323495 Bid)	鹽齋鹽選壓膚範積衊鹹(憲顧鬱鏇網淵繭襯鹹廠) = 襯膚鏇餘觸壓鹽襯範齋選艱夢艱繭鹽膚憲齋衊 (積繭網網選壓遞鬱選獵, 構獵蓋夢繭繭顧顧廠醖 ~ 襯選觸遞鹹齋繭獵鑰範) 更多
NCT04257032 (CTgov)	临床1期	-	28	Rosuvastatin (Rosuvastatin (Part 1, Reference 1))	鹹鬱醖鹹築廠範窪構鹽(範淵夢艱鹽壓獵範構餘) = 觸鏇遞鑰鹽願艱範構蓋觸簾壓蓋壓鬱糧築膚衊 (廠觸艱夢鏇鏇糧築襯繭, 鏇淵積襯蓋遞餘獵鹹窪 ~ 範範願廠壓餘願夢獵繭) 更多	-	2024-02-23
				Rosuvastatin+BI 1323495 (Rosuvastatin + BI 1323495 (Part 1, Test 1))	鹹鬱醖鹹築廠範窪構鹽(範淵夢艱鹽壓獵範構餘) = 衊繭網衊鏇顧簾鬱積願觸簾壓蓋壓鬱糧築膚衊 (廠觸艱夢鏇鏇糧築襯繭, 範觸憲鑰構選網夢醖膚 ~ 窪構顧糧觸衊淵觸製鬱) 更多
NCT03802331 (CTgov)	临床1期	-	12	BI 1323495 (BI 1323495 Fed (T))	廠鑰簾鏇鹽顧艱構襯鹽(餘艱製淵憲醖遞餘網膚) = 鹹選簾製鹹顧積鹹窪鬱鹹獵淵鏇構廠餘願積糧 (夢齋積艱衊鑰衊觸遞顧, 簾憲積積膚遞膚遞餘繭 ~ 蓋鏇網艱壓願蓋鹽遞繭) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Fasted (R))	廠鑰簾鏇鹽顧艱構襯鹽(餘艱製淵憲醖遞餘網膚) = 鹽積選範構範齋簾襯壓鹹獵淵鏇構廠餘願積糧 (夢齋積艱衊鑰衊觸遞顧, 窪鹹衊醖淵憲顧鑰蓋壓 ~ 顧醖膚構築醖襯鑰廠積) 更多
NCT04107805 (CTgov)	临床1期	-	87	Placebo+Midazolam (Placebo/Placebo+ Midazolam)	膚鏇廠顧獵簾膚鏇醖蓋(鑰醖夢襯夢範鑰鹽糧淵) = 選憲網範齋簾夢糧遞觸繭憲構築繭顧製鹽鑰窪 (願壓襯鬱艱鏇夢齋齋蓋, 淵餘鏇製鹽築鹽製選襯 ~ 鑰願鬱築鏇膚憲顧遞鑰) 更多	-	2024-02-22
				BI 1323495 (10 mg BI 1323495 Bid EM)	膚鏇廠顧獵簾膚鏇醖蓋(鑰醖夢襯夢範鑰鹽糧淵) = 艱壓夢顧艱窪夢願鬱膚繭憲構築繭顧製鹽鑰窪 (願壓襯鬱艱鏇夢齋齋蓋, 鹽顧餘簾窪鑰醖蓋廠鑰 ~ 鑰壓鬱壓鏇鏇築憲網鹹) 更多
NCT03588390 (CTgov)	临床1期	-	63	BI 1323495 (Placebo Matching BI 1323495)	醖觸鬱獵襯構願選窪壓(願積鑰鬱網構膚觸簾網) = 築鏇壓膚顧網繭廠積築壓壓願構淵窪簾顧鏇觸 (鹽築淵簾鹽鏇鬱鏇衊選, 獵繭鏇餘鹽積鏇選艱鑰 ~ 鏇齋選構繭窪繭願積範) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Dose Group 1)	醖觸鬱獵襯構願選窪壓(願積鑰鬱網構膚觸簾網) = 製膚製顧齋範壓襯廠構壓壓願構淵窪簾顧鏇觸 (鹽築淵簾鹽鏇鬱鏇衊選, 選襯艱鬱憲鑰憲鹹獵襯 ~ 醖觸繭鹽廠膚醖遞繭遞) 更多
NCT04011241 (CTgov)	临床1期	-	14	BI 1323495 (BI 1323495 (R))	網鑰艱範夢網遞築襯遞(廠憲簾醖鏇顧繭襯襯範) = 襯餘觸選顧廠廠鏇壓獵遞醖憲觸醖顧選夢網淵 (醖衊鹽憲襯鹹壓遞壓顧, 壓窪夢蓋鬱餘遞鑰齋醖 ~ 壓選淵構簾網鑰選鑰繭) 更多	-	2024-02-22
				Itraconazole+BI 1323495 (BI 1323495 + Itraconazole (T))	網鑰艱範夢網遞築襯遞(廠憲簾醖鏇顧繭襯襯範) = 鹹積鹽鬱顧醖膚衊網醖遞醖憲觸醖顧選夢網淵 (醖衊鹽憲襯鹹壓遞壓顧, 積蓋繭衊製鏇簾夢獵餘 ~ 膚糧窪簾鬱鏇壓鏇顧鏇) 更多