Healthy
Conditions
Brief summary
To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.
Interventions
DRUGBI 425809
Tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 55 years (incl.) * Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.) * Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Exclusion criteria
* Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range and considered as clinical relevant by investigator * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease judged as clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14) | 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809. | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14). |
| Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14) | 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809. | Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14). |
| Maximum Measured Concentration of BI 425809 in Plasma (Cmax) | Up to 17 days (for detailed timeframe please see description). | Maximum measured concentration of BI 425809 in plasma is reported. Time Frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809. |
| Maximum Measured Concentration of BI 425809 in CSF (Cmax) | 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809. | Maximum measured concentration of BI 425809 in CSF is reported. |
| Concentration of BI 425809 in Plasma at the Time Point 312h (C312) | 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809. | Concentration of BI 425809 in plasma at the time point 312h (C312) is reported. |
| Concentration of BI 425809 in CSF at the Time Point 312h (C312) | 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809. | Concentration of BI 425809 in CSF at the time point 312h (C312) is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Drug-related Adverse Events (AEs) | From the first drug administration until 11 days after the last drug administration, up to 30days. | Percentage of participants with drug-related adverse events (AEs). |
Countries
Belgium
Contacts
STUDY_CHAIRBoehringer Ingelheim
Boehringer Ingelheim
Participant flow
Recruitment details
The trial applied a non-randomised, open label, sequential-group, multiple-dose design. Participants were allocated to 4 dose groups of 6 participants each. Each participant was treated once daily for 14 days.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.7 Years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| other Total, other adverse events | 5 / 6 | 5 / 6 | 8 / 8 | 4 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 5 |
Outcome results
None listed