Phase 1
N=57
Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Versus Placebo
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02657408 ↗Enrolled (actual)
57
Serious AEs
3.5%
Results posted
Jul 2019
Primary outcome: Primary: Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge — 687.02; 872.61 cells*10^3/mililiter (mL) — p=0.3043
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 1026706 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge |
687.02; 872.61 | 0.3043 |
| SECONDARY Differential Cell Count of Neutrophils in BAL Fluid 24 h After Segmental LPS Challenge. |
54.83; 55.41 | — |
| SECONDARY Total Cell Count of Eosinophil in BAL Fluid After 24 Hours of the Segmental LPS Challenge |
6.95; 10.72 | — |
| SECONDARY Differential Cell Count of Eosinophil in BAL Fluid 24 h After Segmental LPS Challenge. |
0.55; 0.65 | — |
| SECONDARY Total Cell Count of Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge |
240.04; 310.79 | — |
| SECONDARY Differential Cell Count of Monocyte in BAL Fluid 24 h After Segmental LPS Challenge. |
19.16; 19.73 | — |
| SECONDARY Total Cell Count of Macrophage+Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge |
488.95; 575.43 | — |
| SECONDARY Differential Cell Count of Macrophage+Monocyte in BAL Fluid 24 h After Segmental LPS Challenge. |
39.03; 36.54 | — |
| SECONDARY Total Cell Count of Lymphocyte in BAL After 24 Hours of the Segmental LPS Challenge |
20.99; 16.91 | — |
| SECONDARY Differential Cell Count of Lymphocyte in BAL Fluid 24 h After Segmental LPS Challenge. |
1.67; 1.07 | — |
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.
Eligibility Criteria
Inclusion criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT02657408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.