HealthyPhase 1NCT02657408
Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Versus Placebo
A Phase 1 study testing BI 1026706 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1026706
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2016to 13 Mar 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent consistent with ICH-Good Clinical Practice (GCP) guidelines and local legislation prior to participation in the trial.
- Healthy volunteers of both sex between 18 and 65 years (inclusive) of age, on the day of subject's signature of informed consent.
- Healthy subjects as assessed by the investigator, based on a screening examination including medical history, physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, lung function and clinical laboratory results.
- Forced expiratory volume (FEV1) of >80% and FEV1/Forced vital capacity(fFVC) of >70% of the predicted normal value at screening
- Current smokers with a smoking history of at least 1 pack year and with at least 1 cigarette per day in the previous year
- BMI (Body mass index) range: >18.5 and < 29.9kg/m2.
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- Negative urine drug screening.
- Negative breath alcohol test.
- Negative skin prick test (performed within the 12 months prior to study start or at study start)
- Females NOT of childbearing potential are defined as: Women who are postmenopausal (12 months with no menses without an alternative medical cause; in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory) or who are permanently sterilized (defined as hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
- Further inclusion criteria apply
Who cannot join
- History of any relevant lung disease (i.e. Chronic Obstructive Pulmonary Disease (COPD), asthma, chronic bronchitis, pulmonary fibrosis, pulmonary alveolar proteinosis (PAP), pneumocystis infection, active tuberculosis, silicosis or any other lung surfactant overproduction syndromes).
- Subjects with clinically relevant abnormal hematology, blood chemistry, or urinalysis at the screening visit
- Any finding of the medical examination (including blood pressure, pulse rate, body temperature and ECG) deviating from normal and of clinical relevance.
- Subjects with a history of any clinically significant cardiovascular, metabolic, renal (including renal stones), hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric or other major disorders.
- Subjects with a malignancy for which the subject has undergone resection, radiation therapy or chemotherapy within the last five years. Subjects with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed to participate.
- Subjects with previous surgery of the gastro-intestinal tract likely to affect drug absorption.
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- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Subjects with clinically relevant infection or known ongoing clinically relevant inflammatory process.
- History of relevant allergy/hypersensitivity including allergy to drug or its excipients or medications in line with bronchoscopy (bronchodilators, sedatives and local anesthetics).
- Subjects with a marked baseline prolongation of QT/QTcB interval (such as repeated demonstration of a QTcB interval >450 ms), or any other relevant ECG finding at screening visit (Visit 1) according to the investigator.
- Neutrophil blood count indicative of immunosuppression according to the investigator at screening visit (Visit 1).
- Subjects with previous surgeries that may have left ferromagnetic material in the body, ferromagnetic implants or pacemakers.
- Participation in another study with any investigational product within 2 months prior to screening or if screening occurs within 6 half-lives of intake of another investigational drug (whichever is greater).
- Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the trial medication treatment has finished.
- Subjects who are committed to an institution by way of official or juridical order will not be enrolled in the trial.
- Receipt of live (attenuated) vaccine within the 4 weeks prior to screening or during the trial.
- Subject is assessed as unsuitable for inclusion by the investigator; for instance, because he is not considered able to understand and comply with study requirements or has a condition that would not allow safe participation in the study.
- For female subjects:
- Positive pregnancy test at screening Visit 1, pregnancy or plans to become pregnant within 30 days after study completion
- Lactation
- Further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase I Trial in Healthy Male Current Smoker Subjects to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response and Safety of 4 Weeks Oral Administration of BI 1026706
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.
- Conditions
- Healthy
- Being tested
- BI 1026706, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1026706Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1026706 | Experimental | Not described Receives: Drug: BI 1026706 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge
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.
Measured: Day 29
Secondary outcomes (9)
Differential Cell Count of Neutrophils in BAL Fluid 24 h After Segmental LPS Challenge.
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.
Measured: Day 29
Total Cell Count of Eosinophil in BAL Fluid After 24 Hours of the Segmental LPS Challenge
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.
Measured: Day 29
Differential Cell Count of Eosinophil in BAL Fluid 24 h After Segmental LPS Challenge.
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.
Measured: Day 29
Total Cell Count of Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge
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.
Measured: Day 29
Differential Cell Count of Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.
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.
Measured: Day 29
Total Cell Count of Macrophage+Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge
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.
Measured: Day 29
Differential Cell Count of Macrophage+Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.
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.
Measured: Day 29
Total Cell Count of Lymphocyte in BAL After 24 Hours of the Segmental LPS Challenge
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.
Measured: Day 29
Differential Cell Count of Lymphocyte in BAL Fluid 24 h After Segmental LPS Challenge.
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.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start11 Mar 2016
- Primary completion14 Feb 2017
- Study completion13 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657408
- Sponsor's protocol ID
- 1320.17
- Other IDs
- 2015-001789-25, 2015
- Status last verified
- Apr 2019
- First submitted
- 14 Jan 2016
- Last updated
- 10 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Gress C, Vogel-Claussen J, Badorrek P, Muller M, Hohl K, Konietzke M, Litzenburger T, Seibold W, Gupta A, Hohlfeld JM. The effect of bradykinin 1 receptor antagonist BI 1026706 on pulmonary inflammation after segmental lipopolysaccharide challenge in healthy smokers. Pulm Pharmacol Ther. 2023 Oct;82:102246. doi: 10.1016/j.pupt.2023.102246. Epub 2023 Aug 9.
PubMed 37562641
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase I Trial in Healthy Male Current Smoker Subjects to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response and Safety of 4 Weeks Oral Administration of BI 1026706
- ClinicalTrials.gov ID
- NCT02657408
- Acronym / sponsor ID
- 1320.17
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2016 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 13 Mar 2017 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1026706 | Experimental | Drug: BI 1026706 |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent consistent with ICH-Good Clinical Practice (GCP) guidelines and local legislation prior to participation in the trial.
- Healthy volunteers of both sex between 18 and 65 years (inclusive) of age, on the day of subject's signature of informed consent.
- Healthy subjects as assessed by the investigator, based on a screening examination including medical history, physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, lung function and clinical laboratory results.
- Forced expiratory volume (FEV1) of >80% and FEV1/Forced vital capacity(fFVC) of >70% of the predicted normal value at screening
- Current smokers with a smoking history of at least 1 pack year and with at least 1 cigarette per day in the previous year
Key exclusion criteria (21 listed)
- History of any relevant lung disease (i.e. Chronic Obstructive Pulmonary Disease (COPD), asthma, chronic bronchitis, pulmonary fibrosis, pulmonary alveolar proteinosis (PAP), pneumocystis infection, active tuberculosis, silicosis or any other lung surfactant overproduction syndromes).
- Subjects with clinically relevant abnormal hematology, blood chemistry, or urinalysis at the screening visit
- Any finding of the medical examination (including blood pressure, pulse rate, body temperature and ECG) deviating from normal and of clinical relevance.
- Subjects with a history of any clinically significant cardiovascular, metabolic, renal (including renal stones), hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric or other major disorders.
- Subjects with a malignancy for which the subject has undergone resection, radiation therapy or chemotherapy within the last five years. Subjects with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 1026706 | Drug | BI 1026706 |
| Placebo | Drug | Placebo |
Primary outcome
Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge
Time frame: 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.
9 secondary outcomes
Differential Cell Count of Neutrophils in BAL Fluid 24 h After Segmental LPS Challenge.
Time frame: Day 29
Total Cell Count of Eosinophil in BAL Fluid After 24 Hours of the Segmental LPS Challenge
Time frame: Day 29
Differential Cell Count of Eosinophil in BAL Fluid 24 h After Segmental LPS Challenge.
Time frame: Day 29
Total Cell Count of Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge
Time frame: Day 29
Differential Cell Count of Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.
Time frame: Day 29
Total Cell Count of Macrophage+Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge
Time frame: Day 29
Differential Cell Count of Macrophage+Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.
Time frame: Day 29
Total Cell Count of Lymphocyte in BAL After 24 Hours of the Segmental LPS Challenge
Time frame: Day 29
Differential Cell Count of Lymphocyte in BAL Fluid 24 h After Segmental LPS Challenge.
Time frame: Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37562641Gress C, Vogel-Claussen J, Badorrek P, Muller M, Hohl K, Konietzke M, Litzenburger T, Seibold W, Gupta A, Hohlfeld JM. The effect of bradykinin 1 receptor antagonist BI 1026706 on pulmonary inflammation after segmental lipopolysaccharide challenge in healthy smokers. Pulm Pharmacol Ther. 2023 Oct;82:102246. doi: 10.1016/j.pupt.2023.102246. Epub 2023 Aug 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1026706 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.