Healthy
Conditions
Brief summary
The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.
Interventions
DRUGBI 1815368
BI 1815368
DRUGPlacebo matching BI 1815368
Placebo matching BI 1815368
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12- lead Electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 45 years (inclusive) * Body mass index (BMI) of 18.5 to 25 kg/m2 (inclusive) * Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
Exclusion criteria
* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 90 beats per minute (bpm) * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * History of relevant orthostatic hypotension, fainting spells, or blackouts Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator | Up to 26 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MD part: Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) | Up to 19 days | Multiple dose (MD) |
| MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) | Up to 19 days | Multiple dose (MD) |
| SRD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 6 days | Single-rising dose (SRD) |
| SRD part: Maximum measured concentration of the analyte in plasma (Cmax) | Up to 6 days | Single-rising dose (SRD) |
| MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) | Up to 19 days | Multiple dose (MD) |
Countries
Japan
Outcome results
None listed