Healthy
Conditions
Brief summary
To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs. fed (food effect for the tablet).
Interventions
DRUGBI 113823 solution
DRUGBI 113823 tablet
DRUGPlacebo
only for dose group 5
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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 2. Age ≥18 and Age ≤45 years 3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index) 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion criteria
1. Any finding of the medical examination (including BP, PR 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 at least one month or less than 10 half-lives of the respective drug prior to administration 10. 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 11. Participation in another trial with an investigational drug within two months prior to administration or during the trial 12. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) 13. Inability to refrain from smoking on trial days 14. Alcohol abuse (more than 30 g/day) 15. Drug abuse 16. Blood donation (more than 100 mL within four weeks prior to administration) 17. Excessive physical activities (within one week prior to administration) 18. Any laboratory value outside the reference range that is of clinical relevance 19. Inability to comply with dietary regimen of trial site 20. Bradycardia \< 50/min, PR interval \> 200 ms, QRS interval \> 110 ms, QTcB \> 450 ms, or QT (uncorrected) \> 470 ms or any other relevant ECG findings at screening 21. A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinically significant findings on physical examination | up to 14 days after last drug administration | — |
| Number of participants with clinically significant findings in vital signs | up to 14 days after last drug administration | blood pressure (BP), pulse rate (PR) |
| Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG) | up to 14 days after last drug administration | special attention to QRS prolongation |
| Number of participants with clinically significant findings in laboratory tests | up to 14 days after last drug administration | — |
| Number of participants with adverse events | up to 14 days after last drug administration | — |
| Assessment of tolerability by investigator on a 4-point scale | up to 14 days after last drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| MRToral (mean residence time of the analyte in the body after oral administration) | up to 72 hours after drug administration |
| CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) | up to 72 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 72 hours after drug administration |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 72 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 72 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 72 hours after drug administration |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | up to 72 hours after drug administration |
| tmax (time from dosing to maximum measured concentration) | up to 72 hours after drug administration |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 72 hours after drug administration |
| AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 72 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 72 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 72 hours after drug administration |
Outcome results
None listed