BI 894416 / Boehringer Ingelheim - LARVOL DELTA

3D Printing via Melt Extrusion Deposition Facilitates the Use of Extended-Release Profiles in Preclinical Research and Development. (PubMed, Mol Pharm) - "These results further confirmed the likely absorption of BI 894416 in the upper gastrointestinal (GI) tract and the potentially ascending colon. These findings highlight the potential of MED 3D printing to streamline the development of MR formulations in preclinical settings, offering a flexible, efficient, and material-sparing alternative to conventional approaches."

Journal • Preclinical

A radioactivity-mass spectrometry calibration method coupled with biosynthesis to generate a metabolite standard for enzyme kinetics studies. (PubMed, J Pharm Sci) - "We first compared the accuracy of the 14C calibration method to the use of authentic standards for quantitating imipramine metabolites. Next, we biosynthesized and quantitated the metabolites of BI 894416 using 14C calibration method and evaluated the enzyme kinetics of metabolite formation. The Km values of the metabolite formation demonstrated substantially improved accuracy compared to MS semi-quantitation. Moreover, the 14C calibration method offers a streamlined approach to prepare multiple metabolite standards from a single biosynthesis, reducing the time required for structure elucidation and metabolite synthesis."

Journal

This Study in Healthy Men Tests How Different Doses of BI 894416 Are Taken up in the Body and How Well BI 894416 is Tolerated (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Boehringer Ingelheim | N=20 ➔ 68

Enrollment change

Synthesis of BI 894416 and BI 1342561, Two Potent and Selective Spleen Tyrosine Kinase Inhibitors, Labelled with Carbon 14 and with Deuterium. (PubMed, J Labelled Comp Radiopharm) - "Most of the metabolites of compound 1 for example, are the result of tert-butyl oxidation, like alcohol 3, acid 4 and the further N-demethylation of 4 to 5. The detailed preparation of these deuterium labelled metabolites is also described."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • SYK

A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body (clinicaltrials.gov) - P1; N=24; Terminated; Sponsor: Boehringer Ingelheim; Completed ➔ Terminated; Due to company decision.

Clinical • Trial termination

A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated (clinicaltrials.gov) - P1; N=8; Terminated; Sponsor: Boehringer Ingelheim; N=24 ➔ 8; Trial completion date: Feb 2021 ➔ Nov 2020; Recruiting ➔ Terminated; due to company decision

Clinical • Enrollment change • Trial completion date • Trial termination

Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=68; Completed; Sponsor: Boehringer Ingelheim; Recruiting ➔ Completed; Trial completion date: Feb 2021 ➔ Oct 2020; Trial primary completion date: Feb 2021 ➔ Oct 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Asthma • Immunology • Respiratory Diseases

A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Boehringer Ingelheim; Recruiting ➔ Completed; N=42 ➔ 24; Trial completion date: Mar 2021 ➔ Sep 2020; Trial primary completion date: Mar 2021 ➔ Sep 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date

A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • New P1 trial

Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Aug 2020 ➔ Jan 2021

Trial completion date • Asthma • Respiratory Diseases

A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Boehringer Ingelheim; Suspended ➔ Recruiting

Clinical • Enrollment open

A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body (clinicaltrials.gov) - P1; N=42; Suspended; Sponsor: Boehringer Ingelheim; Trial completion date: Aug 2020 ➔ Nov 2020; Trial primary completion date: Aug 2020 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date

Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Boehringer Ingelheim; Suspended ➔ Recruiting

Clinical • Enrollment open • Asthma • Immunology • Respiratory Diseases

Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=80; Suspended; Sponsor: Boehringer Ingelheim; Trial completion date: Apr 2020 ➔ Jul 2020; Trial primary completion date: Apr 2020 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date • Asthma • Immunology • Respiratory Diseases

Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=80; Suspended; Sponsor: Boehringer Ingelheim; Recruiting ➔ Suspended

Clinical • Trial suspension

A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body (clinicaltrials.gov) - P1; N=42; Suspended; Sponsor: Boehringer Ingelheim; Recruiting ➔ Suspended

Trial suspension

A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • New P1 trial

A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 894416 in the Blood (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 894416 in the Blood (clinicaltrials.gov) - P1; N=16; Active, not recruiting; Sponsor: Boehringer Ingelheim; Recruiting ➔ Active, not recruiting

Enrollment closed

A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 894416 in the Blood (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 894416 in the Blood (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • New P1 trial

Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open