Healthy
Conditions
Brief summary
The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses. The main objective of the food effect part is to investigate the influence of food on the relative bioavailability of BI 1819479.
Interventions
DRUGBI 1819479
BI 1819479
DRUGPlacebo
Placebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
single rising dose part is single-blind, randomized, placebo-controlled within parallel dose groups. food effect part is randomized, open-label, two-way, two-period, crossover design.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male subjects according to the assessment of the investigator, as 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 (inclusive) 3. BMI of 18.5 to 29.9 kg/m2 (inclusive) 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) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (ALT/AST) or renal parameters (creatinine) exceeding the ULN after repeated measurements 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. History of relevant orthostatic hypotension, fainting spells, or blackouts -Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with drug-related adverse events | Up to Day 36 | Single rising doses (SRD) part |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Up to Day 31 | Food effect part |
| Maximum measured concentration of the analyte in plasma (Cmax) | Up to Day 31 | Food effect part |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum measured concentration of the analyte in plasma (Cmax) | Up to Day 31 | SRD part |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Up to Day 31 | SRD part |
| Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to Day 31 | Food effect part |
Countries
Germany
Outcome results
None listed