Healthy, Pain
Conditions
Brief summary
As a transition from preclinical investigations to clinical development in this first-in-human trial, safety, tolerability, and pharmacokinetics of BI 660848 will be assessed in human male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 660848 in the indication of neuropathic pain.
Interventions
DRUGBI 660848
2 mg oral drinking solution
DRUGPlacebo
matching placebo (oral drinking solution and IR tablets)
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, 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. 2. Age 21 and 50 years 3. BMI 18.5 and \<30 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 measurements) deviating from normal and of clinical relevance 2. Evidence of a clinically relevant concomitant disease 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 5. History of relevant orthostatic hypotension, fainting spells or blackouts 6. Chronic or relevant acute infections 7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator 8. 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 9. 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 10. Participation in another trial with an investigational drug within 2 months prior to randomisation 11. Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day) 12. Inability to refrain from smoking on trial days as judged by the investigator 13. Alcohol abuse (more than 30 g alcohol a day) 14. Drug abuse 15. Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial) 16. Excessive physical activities within 1 week prior to randomisation or during the trial 17. Any laboratory value outside the reference range that is of clinical relevance 18. Inability to comply with dietary regimen of the study centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability (number and intensity of adverse events). | 4 months |
| Changes in blood pressure. | 4 months |
| Changes in pulse rate. | 4 months |
| Changes in respiratory rate. | 4 months |
| Changes in 12-lead ECG. | 4 months |
| Changes in clinical laboratory test parameters. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose) | 3 days |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | 3 days |
| Cmax (maximum measured concentration of the analyte in plasma) | 3 days |
| CL R,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | 3 days |
| fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2) | 3 days |
| tmax (time from dosing to maximum measured concentration) | 3 days |
| AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 3 days |
| t1/2 (terminal half-life of the analyte in plasma) | 3 days |
| MRT (mean residence time of the analyte in the body after drug intake) | 3 days |
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | 3 days |
Countries
Germany
Outcome results
None listed