Clinical trials: sponsored by Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood
In order to assess the potential impact of steady state BI 425809 on CYP3A clinically, the effect of BI 425809 on the midazolam pharmacokinetics will be evaluated. Midazolam is a recommended substrate of CYP3A4.
- Trial name
- NCT05258110
- Testing
- midazolam, iclepertin (BI 425809)
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood
The main objective of this trial is to investigate the relative bioavailability of BI 425809 given alone (Reference) compared to a combined administration with the moderate CYP3A4 inducer bosentan (Test) following repeated oral…
- Trial name
- NCT05723874
- Testing
- BI 425809, Bosentan
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 425809 in the Blood
The primary objective of this trial is to investigate the relative bioavailability of a single dose of BI 425809 when given alone (Reference, B) compared with co-administration (Test, A) on the 7th day of a 10-day treatment with…
- Trial name
- NCT03082183
- Testing
- Rifampicin, BI 425809
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Insufficiency
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems
This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2.
- Trial name
- NCT05718843
- Testing
- BI 425809
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet
The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to [C-14]-BI 425809 administered as intravenous microtracer (Reference, R).
- Trial name
- NCT03783000
- Testing
- BI 425809, [C-14]-BI 425809
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body
This trial intends to investigate the basic pharmacokinetics of BI 425809 and [14C]- radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 25 mg BI 425809 (C-14) given to healthy…
- Trial name
- NCT03654170
- Testing
- BI 425809 mixed with [C-14] BI425809
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Depressive Disorder, Major
A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine
This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work.
- Trial name
- NCT06280235
- Testing
- BI 1569912
- Where
- 52 sites in United States, Belgium and 5 more
- Volunteers
- 243 people
- Sponsor
- Boehringer Ingelheim
Heart Failure
Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.
- Trial name
- NCT05262764
- Testing
- JARDIANCE®
- Where
- Japan
- Volunteers
- 1,200 people
- Sponsor
- Boehringer Ingelheim
Netherton Syndrome
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome
This study is open to people with a skin disease called Netherton syndrome (NS). People can join the study if they are 12 years or older.
- Trial name
- NCT05856526
- Testing
- Spesolimab - solution for infusion, Spesolimab - solution for injection
- Where
- 28 sites in United States, Australia and 12 more
- Volunteers
- 43 people
- Sponsor
- Boehringer Ingelheim
Lung Diseases, Interstitial
A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)
This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study called InPedILD (study 1199-0337) and for people who are…
- Trial name
- NCT05285982
- Testing
- Nintedanib (Ofev®)
- Where
- 28 sites in United States, Argentina and 15 more
- Volunteers
- 54 people
- Sponsor
- Boehringer Ingelheim
Liposarcoma, Dedifferentiated
Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.
- Trial name
- NCT05218499
- Testing
- Brigimadlin, Doxorubicin
- Where
- 109 sites in United States, Australia and 20 more
- Volunteers
- 400 people
- Sponsor
- Boehringer Ingelheim
Lung Diseases, Interstitial
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a…
- Trial name
- NCT04559581
- Testing
- Nintedanib
- Where
- Japan
- Volunteers
- 425 people
- Sponsor
- Boehringer Ingelheim
Schizophrenia
CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning.
- Trial name
- NCT04860830
- Testing
- Iclepertin
- Where
- 110 sites in United States, Argentina and 16 more
- Volunteers
- 609 people
- Sponsor
- Boehringer Ingelheim
Neoplasms
A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours
The main objective of the dose-escalation part of the trial is to determine the safety and tolerability, and to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D) of BI 754091 on the basis of patients…
- Trial name
- NCT02952248
- Testing
- BI 754091
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 110 people
- Sponsor
- Boehringer Ingelheim
Neoplasm Metastasis, Advanced Tumors
Platform Trial Evaluating Safety and Efficacy of Ezabenlimab Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours
This is a study in adults with various types of advanced cancer. The purpose of the study is to test a medicine called BI 754091 in combination with several other cancer medicines. BI 754091 is an immunotherapy.
- Conditions
- Neoplasm Metastasis, Advanced Tumors, Metastatic Solid Tumors
- Trial name
- NCT03697304
- Testing
- Ezabenlimab, BI 754111, BI 836880
- Where
- 17 sites in United States, Canada and 1 more
- Volunteers
- 211 people
- Sponsor
- Boehringer Ingelheim
Neoplasms, Carcinoma, Non-Small-Cell Lung
This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.
This is a study in adults with advanced solid tumors including non-small cell lung cancer. The study tests the combination of two medicines called BI 754111 and BI 754091 that may help the immune system to fight the cancer.
- Trial name
- NCT03156114
- Testing
- Ezabenlimab, BI 754111
- Where
- 15 sites in United States, Canada and 3 more
- Volunteers
- 172 people
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How BI 1291583 is Processed in the Body
The main objective of this trial is to Assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces following a dose of BI 1291583 (C-14) Provide plasma and urine samples for pharmacokinetic…
- Trial name
- NCT05833035
- Testing
- BI 1291583 mixed with [C-14] BI 1291583
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Liver Cirrhosis
A Study to Compare How Different Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Handled by the Body of Healthy People and People With Liver Cirrhosis
This study is open to healthy adults and adults with liver cirrhosis. The purpose of this study is to compare how different medicines are handled by the body in people with and without liver cirrhosis.
- Trial name
- NCT05741372
- Testing
- Rosuvastatin, Digoxin, Metformin hydrochlorid
- Where
- Germany
- Volunteers
- 28 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms
This Study Tests How BI 754111 is Distributed in Patients With Advanced Non-small Cell Lung Cancer or Patients With Head and Neck Cancer Who Are Treated With BI 754091
The main objective of this study is to determine the biodistribution and intra-tumor accumulation of [89Zr]Zr-BI 754111 at baseline and its change upon treatment
- Trial name
- NCT03780725
- Testing
- BI 754111, [89Zr]Zr-BI 754111, BI 754091
- Where
- Netherlands
- Volunteers
- 8 people
- Sponsor
- Boehringer Ingelheim
Kidney Disease, Chronic
A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis
This study is open to adults with a type of kidney disease called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in…
- Trial name
- NCT05213624
- Testing
- BI 764198
- Where
- 54 sites in United States, Australia and 8 more
- Volunteers
- 67 people
- Sponsor
- Boehringer Ingelheim
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