Clinical trials: sponsored by Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood
The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1358894 administered as tablet formulation 2 (TF2a, TF2b) under fasted conditions compared with the tablet formulation 1 (TF1)…
- Trial name
- NCT03892616
- Testing
- BI 1358894 (B), BI 1358894 (C), BI 1358894 (D)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body
The main objective of this trial is to investigate the basic pharmacokinetics of BI 1358894 and its metabolites, total radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of [14C]…
- Trial name
- NCT04567316
- Testing
- [14C]-radiolabelled BI 1358894, BI 1358894
- Where
- Netherlands
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test the Influence of BI 1358894 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood
The main objective of this trial is to investigate the relative bioavailability of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1358894 (Test 1, Test 2) following oral…
- Trial name
- NCT04099732
- Testing
- Rosuvastatin, BI 1358894, Dabigatran etexilate
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food
To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI…
- Trial name
- NCT05155306
- Testing
- BI 1358894, intended Commercial Formulation (iCF) (T), BI 1358894, Trial Formulation 2 (TFII) (R)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1358894 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT03875001
- Testing
- Dose group 1 - 50 mg BI 1358894, Dose group 2 - 100 mg BI 1358894, Dose group 3 - 200 mg BI 1358894
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pulmonary Disease, Chronic Obstructive
Assessment of Health-related Quality of Life After Switching COPD Patients From a Dry Powder Inhaler to a Soft Mist Inhaler Remaining on the Same Inhalative Drug
The objective of this non-interventional, observational study is to assess whether changing Chronic Obstructive Pulmonary Disease (COPD) patients from a dry powder inhaler (HandiHaler®) to a soft mist inhaler (Respimat®), without…
- Trial name
- NIS PIRATE (NCT05362487)
- Testing
- Spiriva® Respimat®, Spiriva® HandiHaler®, Tiotropium bromide
- Where
- Switzerland
- Volunteers
- 9 people
- Sponsor
- Boehringer Ingelheim
Hemorrhage
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in…
- Trial name
- NCT03343704
- Testing
- Idarucizumab
- Where
- 13 sites in China
- Volunteers
- 19 people
- Sponsor
- Boehringer Ingelheim
Depressive Disorder, Major
A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are Involved in Emotions
To assess the effect of a single dose of BI 1358894 compared to placebo on BOLD responses in modulating brain processing of emotional and cognitive stimuli on the amygdala and related brain structure using fMRI in in unmedicated…
- Trial name
- NCT03854578
- Testing
- BI 1358894, Citalopram
- Where
- Germany
- Volunteers
- 73 people
- Sponsor
- Boehringer Ingelheim
Generalized Pustular Psoriasis
An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options
This Expanded Access trial in Japan is open to people with a serious skin disease called Generalized Pustular Psoriasis (GPP). This program provides a medicine called spesolimab to people with a GPP flare-up who have no…
- Trial name
- NCT05200247
- Testing
- spesolimab
- Where
- 9 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
This study aims to investigate the effect of multiple doses of BI 1358894 on pharmacokinetics of ethinylestradiol (EE) and drospirenone (DRSP) (Yasmin®)
- Trial name
- NCT05934942
- Testing
- Yasmin®, BI 1358894
- Where
- Germany
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men and Women to Test Whether BI 1358894 Influences the Amount of Bupropion in the Blood
The main objective of this trial is to investigate the relative bioavailability of a single dose of bupropion when given alone (Reference) compared with co-administration (Test) with BI 1358894 in healthy volunteers.
- Trial name
- NCT04899674
- Testing
- Elontril, BI 1358894
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Fibrostenotic Crohn´s Disease
A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction
This study is open to adults, between 18 and 75 years of age, who have narrowings in the small bowel (strictures) due to Crohn's disease. Strictures can lead to bowel obstruction (blockage).
- Trial name
- NCT05013385
- Testing
- Spesolimab
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim
Dermatitis, Atopic
A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
To assess the long term safety and efficacy of treatment with BI 655130 in patients with AD who have completed and have responded to treatment in the parent study 1368-0032
- Trial name
- NCT04086121
- Testing
- Spesolimab
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 14 people
- Sponsor
- Boehringer Ingelheim
Breast Neoplasms
The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread
The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and…
- Trial name
- NCT03659136
- Testing
- Xentuzumab, Everolimus, Exemestane
- Where
- 54 sites in United States, Australia and 9 more
- Volunteers
- 103 people
- Sponsor
- Boehringer Ingelheim
Crohn Disease
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of…
- Trial name
- NCT04362254
- Testing
- Spesolimab
- Where
- 7 sites in Austria, Belgium and 3 more
- Volunteers
- 12 people
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood
The main objective of this trial is to investigate the relative bioavailability of BI 1358894 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as…
- Trial name
- NCT03843151
- Testing
- BI 1358894, Itraconazole
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung
Afatinib in NSCLC With HER2 Mutation
to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2 mutations, previously treated with 1 or 2 chemotherapy regimens
- Trial name
- NCT02597946
- Testing
- afatinib, paclitaxel
- Where
- 9 sites in China, Malaysia
- Volunteers
- 18 people
- Sponsor
- Boehringer Ingelheim
Gastrointestinal Cancer, Metastatic
A Study to Find the Best Dose of BI 905711 in Combination With Chemotherapy and to Test Whether This Dose Helps People With Advanced Gastrointestinal Cancers
This study is open to adults with advanced colorectal cancer or with advanced pancreatic cancer. The study has 2 parts. In the first part, participants with colorectal cancer get a medicine called BI 905711 combined with…
- Trial name
- NCT05087992
- Testing
- BI 905711, FOLFIRI, Bevacizumab
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 13 people
- Sponsor
- Boehringer Ingelheim
Geographic Atrophy
A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
This study is open to adults with geographic atrophy, an advanced form of age-related macular degeneration. People can join the study if they are at least 50 years old.
- Trial name
- NCT06006585
- Testing
- BI 771716
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung
LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma…
- Trial name
- NCT02231164
- Testing
- docetaxel, nintedanib
- Where
- 13 sites in United States, Georgia and 1 more
- Volunteers
- 12 people
- Sponsor
- Boehringer Ingelheim
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