Healthy
Conditions
Brief summary
Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
30 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males according to the following criteria (examined at the Screening Visit): Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests 1.1 No finding deviating from normal and of clinical relevance 1.2 No evidence of a clinically relevant concomitant disease 2. Age ≥30 and ≤55 years 3. BMI ≥18.5 and BMI \< 30 kg/m2 (Body Mass Index) 4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion criteria
1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders 2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 3. History of relevant orthostatic hypotension, fainting spells or blackouts 4. Chronic or relevant acute infections 5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the Investigator 6. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial 7. 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 administration or during the trial 8. Participation in another trial with an investigational drug within two months prior to administration or during the trial 9. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) 10. Inability to refrain from smoking during the trial 11. Alcohol abuse (more than 60 g/day) 12. Drug abuse 13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial) 14. Excessive physical activities (within one week prior to administration or during the trial) 15. Any laboratory value outside the reference range if indicative of underlying disease or poor health
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with abnormal findings in physical examination | up to day 42 | — |
| Number of subjects with clinically significant changes in vital signs | up to day 42 | — |
| Number of subjects with clinically significant changes in 12-lead electrocardiogram | up to day 42 | — |
| Number of subjects with clinically significant changes in laboratory parameters | up to day 42 | — |
| Changes in effective airway resistance (Reff) | up to day 25 | Body plethysmography |
| Changes in specific effective airway conductance (SGeff) | up to day 25 | Body plethysmography |
| Changes in salivary secretion | up to day 21 | — |
| Number of subjects with adverse events | up to day 42 | — |
| Assessment of tolerability by the Investigator on a 4-point rating scale | day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) | up to day 35 |
| Mean residence time of the analyte in the body after 21 administrations at steady state (MRTih,ss) | up to day 35 |
| apparent clearance of the analyte in the plasma after extravascular administration at steady state (CL/F,ss) | up to day 35 |
| Maximum concentration of the analyte in plasma for several time points | up to day 35 |
| Accumulation ratio (RA) of the analyte in plasma after multiple dose administration over a uniform dosing interval τ | up to day 35 |
| Peak trough fluctuation (PTF) | up to day 35 |
| apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss) | up to day 35 |
| Time from dosing to maximum concentration in plasma for several time points | up to day 35 |
| Area under the concentration-time curve of the analyte in plasma for several time points | up to day 35 |
| Amount of analyte that is eliminated in urine for several time points | up to day 34 |
| Fraction of analyte excreted in urine for several time points | up to day 34 |
| Renal clearance of the analyte in plasma for several time points | up to day 34 |
| Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval | up to day 35 |
| Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose | up to day 35 |
| Terminal rate constant in plasma at steady state (λz,ss) | up to day 35 |
Outcome results
None listed