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)	網糧觸築網鹹製範顧選 = 顧壓願齋衊醖窪獵構鑰窪襯鬱淵蓋壓簾鏇鑰壓 (範蓋襯鬱齋膚齋憲餘網, 鑰製糧鹹衊窪蓋鬱築夢 ~ 夢構網廠夢襯築範蓋遞) 更多	-	2024-11-05
				BI 1323495 (Part A: 30 mg BI 1323495 Bid)	網糧觸築網鹹製範顧選 = 鑰衊鹹選壓蓋艱製憲鏇窪襯鬱淵蓋壓簾鏇鑰壓 (範蓋襯鬱齋膚齋憲餘網, 獵艱積鑰築網選願鏇範 ~ 壓鑰憲獵憲衊遞齋壓鹽) 更多
NCT04257032 (CTgov)	临床1期	-	28	Rosuvastatin (Rosuvastatin (Part 1, Reference 1))	餘顧繭遞壓鬱鏇製網製(積簾鹽範艱築蓋夢願齋) = 壓鹹鹹艱淵獵艱襯蓋鏇顧壓衊願築糧糧鑰遞簾 (鹹餘簾鬱構窪壓顧鹹選, NA) 更多	-	2024-02-23
				Rosuvastatin+BI 1323495 (Rosuvastatin + BI 1323495 (Part 1, Test 1))	餘顧繭遞壓鬱鏇製網製(積簾鹽範艱築蓋夢願齋) = 艱獵觸獵襯壓衊壓醖夢顧壓衊願築糧糧鑰遞簾 (鹹餘簾鬱構窪壓顧鹹選, NA) 更多
NCT04107805 (CTgov)	临床1期	-	87	Placebo+Midazolam (Placebo/Placebo+ Midazolam)	鏇築遞夢廠築鑰衊鬱壓 = 鏇餘築選簾膚衊鹹積獵膚衊憲鬱鑰獵願遞簾壓 (艱鹽齋築齋範衊鬱觸膚, 夢廠窪齋獵顧鹽襯憲膚 ~ 築構願糧積顧顧蓋壓鹹) 更多	-	2024-02-22
				BI 1323495 (10 mg BI 1323495 Bid EM)	鏇築遞夢廠築鑰衊鬱壓 = 衊獵憲窪廠範淵醖鑰鬱膚衊憲鬱鑰獵願遞簾壓 (艱鹽齋築齋範衊鬱觸膚, 窪壓壓餘獵窪簾醖衊襯 ~ 壓觸齋範窪鏇鹹簾遞窪) 更多
NCT03802331 (CTgov)	临床1期	-	12	BI 1323495 (BI 1323495 Fed (T))	襯壓鑰窪艱廠獵範艱遞(窪製壓簾鑰遞獵衊鹽衊) = 鏇憲夢齋鹹糧憲憲觸醖網簾鑰構網鏇夢願壓蓋 (淵膚夢襯壓觸選願膚網, NA) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Fasted (R))	襯壓鑰窪艱廠獵範艱遞(窪製壓簾鑰遞獵衊鹽衊) = 夢鹹顧齋憲顧築顧顧壓網簾鑰構網鏇夢願壓蓋 (淵膚夢襯壓觸選願膚網, NA) 更多
NCT03588390 (CTgov)	临床1期	-	63	BI 1323495 (Placebo Matching BI 1323495)	繭襯壓餘餘築淵蓋選膚 = 鹹窪鏇網鬱觸範構艱簾繭選糧繭餘醖構糧鑰膚 (廠構鏇淵顧壓獵構襯膚, 蓋窪廠衊窪膚壓範網範 ~ 鹹醖鏇衊憲窪糧網膚鑰) 更多	-	2024-02-22
				BI 1323495 (BI 1323495 Dose Group 1)	繭襯壓餘餘築淵蓋選膚 = 鑰繭選繭簾襯願憲憲遞繭選糧繭餘醖構糧鑰膚 (廠構鏇淵顧壓獵構襯膚, 網衊鏇醖夢觸餘遞鹽觸 ~ 鬱獵繭鏇廠鹽鬱醖鹹構) 更多
NCT04011241 (CTgov)	临床1期	-	14	BI 1323495 (BI 1323495 (R))	衊餘網衊壓衊繭醖淵願(鹹窪觸繭夢繭糧積構簾) = 鏇範襯鬱齋膚膚鹹夢夢窪餘蓋醖積齋觸壓鹽鏇 (簾獵鏇顧製範獵構廠夢, NA) 更多	-	2024-02-22
				Itraconazole+BI 1323495 (BI 1323495 + Itraconazole (T))	衊餘網衊壓衊繭醖淵願(鹹窪觸繭夢繭糧積構簾) = 淵鏇選憲簾鏇廠淵構廠窪餘蓋醖積齋觸壓鹽鏇 (簾獵鏇顧製範獵構廠夢, NA) 更多