NCT02657408 is a Phase 1 clinical trial of BI 1026706 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT02657408?

NCT02657408 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT02657408?

Interventions in NCT02657408: BI 1026706, Placebo.

Is NCT02657408 still recruiting?

NCT02657408 is currently completed. Last updated 10 July 2019.

Are results published for NCT02657408?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-07-10 · How we verify

NCT02657408

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Versus Placebo

Completed Phase 1 Results posted Last updated 10 July 2019

What this trial tests

Phase 1 trial testing BI 1026706 in Healthy in 57 participants. Completed in 13 March 2017.

Timeline

11 March 2016

Primary endpoint
14 February 2017

13 March 2017

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	57
Start date	11 March 2016
Primary completion	14 February 2017
Estimated completion	13 March 2017
Sites	1 location across Germany

Drugs / interventions tested

BI 1026706 — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Eligibility, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge Primary · Day 29

Total cell count of neutrophils in Bronchoalveolar Lavage (BAL) fluid after 24 hours of the segmental Lipopolysaccharide (LPS) challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the Least Square (LS) means obtained by fitting an Analysis of variance (ANOVA) model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Group	Value	95% CI
Placebo	687.02	± 109.315
BI 1026706	872.61	± 145.019

Differential Cell Count of Neutrophils in BAL Fluid 24 h After Segmental LPS Challenge. Secondary · Day 29

Differential cell count of neutrophils in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Group	Value	95% CI
Placebo	54.83	± 3.094
BI 1026706	55.41	± 3.266

Total Cell Count of Eosinophil in BAL Fluid After 24 Hours of the Segmental LPS Challenge Secondary · Day 29

Total cell count of eosinophil in BAL fluid after 24 hours of the segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Group	Value	95% CI
Placebo	6.95	± 2.744
BI 1026706	10.72	± 4.420

Differential Cell Count of Eosinophil in BAL Fluid 24 h After Segmental LPS Challenge. Secondary · Day 29

Differential cell count of eosinophil in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Group	Value	95% CI
Placebo	0.55	± 0.200
BI 1026706	0.65	± 0.246

Total Cell Count of Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge Secondary · Day 29

Total cell count of monocyte in BAL fluid after 24 hours of the segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Monocyte cell count is the only cell count which was assessed by means of flow cytometry.

Group	Value	95% CI
Placebo	240.04	± 34.306
BI 1026706	310.79	± 46.393

Differential Cell Count of Monocyte in BAL Fluid 24 h After Segmental LPS Challenge. Secondary · Day 29

Differential cell count of monocyte (determined by flow cytometry) in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Monocyte cell count is the only cell count which was assessed by means of flow cytometry.

Group	Value	95% CI
Placebo	19.16	± 1.058
BI 1026706	19.73	± 1.138

Total Cell Count of Macrophage+Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge Secondary · Day 29

Total cell count of macrophage+monocyte BAL fluid after 24 hours of the segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together.

Group	Value	95% CI
Placebo	488.95	± 52.417
BI 1026706	575.43	± 64.431

Differential Cell Count of Macrophage+Monocyte in BAL Fluid 24 h After Segmental LPS Challenge. Secondary · Day 29

Differential cell count of macrophage+monocyte in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together.

Group	Value	95% CI
Placebo	39.03	± 2.499
BI 1026706	36.54	± 2.444

Total Cell Count of Lymphocyte in BAL After 24 Hours of the Segmental LPS Challenge Secondary · Day 29

Total cell count of lymphocyte after 24 hours of the segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Group	Value	95% CI
Placebo	20.99	± 3.976
BI 1026706	16.91	± 3.346

Differential Cell Count of Lymphocyte in BAL Fluid 24 h After Segmental LPS Challenge. Secondary · Day 29

Differential cell count of lymphocyte in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Group	Value	95% CI
Placebo	1.67	± 0.283
BI 1026706	1.07	± 0.190

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose administration of the study medication to 4 days after last drug administration; up to 35 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/28 (4%)

Deaths: 0/28

BI 1026706

Serious: 1/29 (3%)

Deaths: 0/29

Serious adverse events (3 terms)

Reaction	System	Placebo	BI 1026706
Post procedural complication	Injury, poisoning and procedural complications	—	—
Presyncope	Nervous system disorders	—	—
Calculus urinary	Renal and urinary disorders	—	—

Other adverse events (17 terms — click to expand)

Reaction	System	Placebo	BI 1026706
Headache	Nervous system disorders	—	—
Post procedural complication	Injury, poisoning and procedural complications	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Pyrexia	General disorders	—	—
Lower respiratory tract infection	Infections and infestations	—	—
Procedural complication	Injury, poisoning and procedural complications	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Respiratory tract infection	Infections and infestations	—	—
Rhinitis	Infections and infestations	—	—
Procedural headache	Injury, poisoning and procedural complications	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Agitation	Psychiatric disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Post procedural complication, Presyncope, Calculus urinary.

Data from ClinicalTrials.gov NCT02657408 adverse events section.

Sponsor's own description

The primary and secondary objectives of the current study are the assessments of anti-inflammatory pharmacodynamic effects on segmental endotoxin induced inflammatory response after 4 weeks treatment with BI 1026706.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Transcriptomic characterization of the human segmental endotoxin challenge model.
Gress C, Litzenburger T, Schmid R, Xiao K, et al · · 2024 · cited 2× · PMID 38242945 · DOI 10.1038/s41598-024-51547-0
The effect of bradykinin 1 receptor antagonist BI 1026706 on pulmonary inflammation after segmental lipopolysaccharide challenge in healthy smokers.
Gress C, Vogel-Claussen J, Badorrek P, Müller M, et al · · 2023 · cited 1× · PMID 37562641 · DOI 10.1016/j.pupt.2023.102246

Verify or expand the search:

Other trials of BI 1026706

Trials testing the same drug.

NCT02652416 — Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers · Phase 1 · completed
NCT02732951 — Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema · Phase 2 · completed
NCT02642614 — Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD · Phase 1 · completed
NCT02513446 — Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1026706 in Healthy Male Sub · Phase 1 · completed
NCT02126826 — Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Fema · Phase 1 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

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NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02657408 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 10 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02657408.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing