Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Versus Placebo
Condition: Healthy
Intervention: BI 1026706; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 57.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

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 < 29.9kg/m2.

          -  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

        Exclusion criteria:

          -  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.

          -  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