Healthy
Conditions
Brief summary
To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast
Interventions
DRUGBI 14332 CL
OTHERhigh fat breakfast
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests * Age ≥21 and Age ≤65 years * Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2 * Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion criteria
* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance * Any evidence of a clinically relevant concomitant disease * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Surgery of the gastrointestinal tract (except appendectomy) * 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 drug or its excipients) * 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 * Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial * Participation in another trial with an investigational drug within two months prior to administration or during the trial * Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Inability to refrain from smoking on trial days * Alcohol abuse (more than 60 g/day) * Drug abuse * Blood donation (more than 100 mL within four weeks prior to administration or during the trial) * Excessive physical activities (within one week prior to administration or during the trial) * Any laboratory value outside the reference range that is of clinical relevance * Inability to comply with dietary regimen of trial site * A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms) * A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 192 hours after drug administration |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 192 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | up to 192 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 192 hours after drug administration |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 192 hours after drug administration |
| AUCt1-t2 (partial area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) | up to 192 hours after drug administration |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | up to 192 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 192 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 192 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 192 hours after drug administration |
| Number of patients with adverse events | up to 23 days after last drug administration |
| Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate) | up to 23 days after last drug administration |
| Number of patients with clinically significant findings in laboratory tests | up to 23 days after last drug administration |
| Number of patients with clinically significant findings in ECG | up to 23 days after last drug administration |
| Assessment of tolerability by investigator on a 4-point scale | up to 23 days after last drug administration |
Outcome results
None listed