Healthy
Conditions
Brief summary
To investigate safety, tolerability, and pharmacokinetics of BI 11054
Interventions
DRUGBI 11054 CL
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease. * Age ≥21 and ≤50 years * Body mass index (BMI) ≥18.5 and \<30 kg/m2 * Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion criteria
* Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance * Evidence of a clinically relevant concomitant disease * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * History of relevant orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections * History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator * Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation * Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation * Participation in another trial with an investigational drug within 2 months prior to randomisation * Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day) * Inability to refrain from smoking on trial days as judged by the investigator * Alcohol abuse (more than 40 g alcohol a day) * Drug abuse * Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial) * Excessive physical activities within 1 week prior to randomisation or during the trial * Any laboratory value outside the reference range that is of clinical relevance * Inability to comply with dietary regimen of the study centre The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with clinically significant findings in physical examination | up to 18 days after drug administration | — |
| Number of subjects with clinically significant findings in vital signs | up to 18 days after drug administration | blood pressure (BP), pulse rate (PR), respiratory rate (RR) |
| Number of subjects with clinically significant findings in orthostasis tests | up to 24 hours after drug administration | — |
| Number of subjects with clinically significant findings in laboratory tests | up to 18 days after drug administration | — |
| Number of subjects with clinically significant findings in additional safety laboratory tests | up to 24 hours after drug administration | cyclic adenosine monophosphate (cAMP) and potassium |
| Number of subjects with clinically significant changes in body temperature | up to 24 hours after drug administration | — |
| Number of subjects with clinically significant findings in electrocardiogram (ECG) | up to 18 days after drug administration | — |
| Number of subjects with adverse events | up to 18 days after drug administration | — |
| Number of subjects with findings of oropharyngeal inspection | up to 24 hours after drug administration | — |
| Number of subjects with findings of pulmonary auscultation | up to 24 hours after drug administration | — |
| Airway resistance (Raw) | up to 24 hours after drug administration | measured by body plethysmography |
| Global tolerability assessed by investigator on a 4-point scale | up to 18 days after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 96 hours |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 96 hours |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 96 hours |
| tmax (time from dosing to maximum measured concentration) | up to 96 hours |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration) | up to 96 hours |
| AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time t1 to time t2) | up to 96 hours |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 96 hours |
| %AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation) | up to 96 hours |
| λz (terminal rate constant in plasma) | up to 96 hours |
| t1/2 (terminal half-life of the analyte in plasma) | up to 96 hours |
| MRTih (mean residence time of the analyte in the body after inhalation) | up to 96 hours |
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | up to 96 hours |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 96 hours |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | up to 96 hours |
Outcome results
None listed