Healthy
Conditions
Brief summary
The main objective of this trial is to investigate the relative bioavailability of vicadrostat and empagliflozin when administered in combination or individually.
Interventions
DRUGVicadrostat
Vicadrostat
DRUGJardiance®
Jardiance®
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 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 55 years (inclusive) * Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (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
Exclusion criteria
: * Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 105 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 65 to 90 mmHg, or pulse rate outside the range of 50 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 Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3) |
| Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4) |
| Maximum measured concentration of vicadrostat in plasma (Cmax) | Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3) |
| Maximum measured concentration of empagliflozin in plasma (Cmax) | Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4) |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz ) | Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3) |
| Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4) |
Countries
Germany
Outcome results
None listed