Healthy
Conditions
Brief summary
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL
Interventions
DRUGBI 1744 CL
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (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 * BMI ≥18.5 and \<30 kg/m2 (Body Mass Index) * 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 60 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 |
|---|---|
| Number of patients with clinically significant changes in physical examination | Baseline, day 32 (end-of-study examination) |
| Number of patients with clinically significant changes in vital signs | Baseline, up to day 32 |
| Number of patients with clinically significant changes in 12-lead ECG (Electrocardiogram) | Baseline, up to day 32 |
| Number of patients with abnormal changes in laboratory tests | Baseline, up to day 32 |
| Changes in airway resistance (Raw) measured by body plethysmography | Baseline, up to day 32 |
| Changes in tremormetry parameters | Baseline, up to day 32 |
| Number of patients with adverse events | Up to day 32 |
| Assessment of tolerability by the investigator on a 4-point scale | Day 32 (end-of-study examination) |
Secondary
| Measure | Time frame |
|---|---|
| MRTih (mean residence time of the analyte in the body after inhalation) | Up to 408 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | Up to 408 hours after drug administration |
| Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following an extravascular dose) | Up to 408 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 until the time point t2) | Up to 408 hours after drug administration |
| Cmax (maximum concentration of the analyte in plasma) | Up to 408 hours after drug administration |
| RA,AUC,14 based on AUC0-τ | Up to 408 hours after drug administration |
| Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | Up to 408 hours after drug administration |
| Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) | Up to 408 hours after drug administration |
| Linearity Index (LI) | Up to 408 hours after drug administration |
| RA,Cmax,14 based on Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) | Up to 408 hours after drug administration |
| tmax (time from dosing to maximum concentration) | Up to 408 hours after drug administration |
| AUC (area under the concentration-time curve of the analyte in plasma at different time points) | Up to 408 hours after drug administration |
| Aet1-t2(amount of analyte that is eliminated in urine from the time point t1 to time point t2) | Up to 384 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | Up to 384 hours after drug administration |
| %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) | Up to 408 hours after drug administration |
| λz (terminal rate constant of the analyte in plasma) | Up to 408 hours after drug administration |
| t½ (terminal half-life of the analyte in plasma) | Up to 408 hours after drug administration |
Outcome results
None listed