Healthy
Conditions
Brief summary
The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.
Interventions
DRUGMatching placebo
Tablet
DRUGBI 1181181 healthy elderly
Tablet
DRUGBI 1181181 Healthy young
Tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests. 2. Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers. 3. BMI of 18.5 to 29.9 kg/m2 (incl.) 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator 2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 3. Any evidence of a concomitant disease judged as clinically relevant by the investigator 4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 5. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy) 6. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency [N (%)] of subjects with drug-related adverse events | days 1 to 24 |
Secondary
| Measure | Time frame |
|---|---|
| Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose | 0 to 336 hours |
| AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) | 0 to 336 hours |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose | 0 to 336 hours |
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose | 0 to 336 hours |
| AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose | 0 to 336 hours |
| Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose | 0 to 336 hours |
Countries
Germany
Outcome results
None listed