Healthy
Conditions
Brief summary
Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese healthy volunteers
Interventions
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Japanese men: According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests 2. Age ≥20 and ≤35 years 3. Body mass index (BMI) ≥18.5 and ≤25 kg/m2 4. Subjects must be able to inhale medication in a competent manner from the Respimat® 5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)
Exclusion criteria
1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance 2. Any evidence of a clinically relevant concomitant disease 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. Surgery of the gastrointestinal tract (except appendectomy) 5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 6. History of relevant orthostatic hypotension, fainting spells or blackouts 7. Chronic or relevant acute infections 8. History of relevant allergy/hypersensitivity including allergy to drug or its excipients 9. Intake of drugs with a long half-life (\>24 hours) within one month or less than 10 half-lives of the respective drug before drug administration or during the trial 10. Use of prescription or non-prescription drugs within 10 days before drug Administration or during the trial. However, over-the-counter (OTC) drugs for external application (such as lubricant eye drops for contact lens, insect bite reliever) shall be allowed 11. Participation in another trial with an investigational drug within four months before drug administration or during the trial 12. Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day) 13. Inability to refrain from smoking during the trial 14. Alcohol abuse (≥60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese shochu, distilled alcoholic beverage) 15. Drug abuse 16. Blood donation (≥100 mL within four weeks before drug administration or during the trial) 17. Excessive physical activities (within one week before drug administration or during the trial) 18. Any laboratory value outside the reference range that is of clinical relevance 19. Inability to comply with dietary regimen of trial site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with abnormal findings in physical examination | up to 28 days after last dose administration | — |
| Number of subjects with clinically significant changes in vital signs | up to 28 days after last dose administration | Blood pressure and pulse rate |
| Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG) | up to 28 days after last dose administration | — |
| Number of subjects with abnormal changes in laboratory parameters | up to 28 days after last dose administration | — |
| Number of subjects with adverse events | up to 28 days after last dose administration | — |
| Assessment of tolerability by the investigator on a 4-point scale | 28 days after last dose administration | — |
Secondary
| Measure | Time frame |
|---|---|
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 648:00 hours |
| Cmin,ss (minimum concentration of the analyte in plasma at steady state) | up to 648:00 hours |
| Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) | up to 648:00 hours |
| λz,ss (terminal rate constant in plasma at steady state) | up to 648:00 hours |
| t1/2,ss (terminal half-life of the analyte in plasma at steady state) | up to 648:00 hours |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 648:00 hours |
| CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration) | up to 648:00 hours |
| Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) | up to 648:00 hours |
| Accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax) | up to 648:00 hours |
| Accumulation ratio of the analyte in plasma based on AUC (RA,AUC) | up to 648:00 hours |
| Accumulation ratio of the analyte in plasma based on Ae (RA,Ae) | up to 648:00 hours |
| MRTih,ss (mean residence time of the analyte in the body at steady state after inhalation administration) | up to 648:00 hours |
| tmax (time from dosing to maximum measured concentration of the analyte in plasma) | up to 648:00 hours |
| AUCτ (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ) | up to 648:00 hours |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz) | up to 648:00 hours |
| Aeτ (amount of analyte that is eliminated in urine over a uniform dosing interval τ) | up to 648:00 hours |
| feτ (fraction of analyte eliminated in urine over a uniform dosing interval τ) | up to 648:00 hours |
Outcome results
None listed