A Study in Healthy Men to Compare the Amount of Vicadrostat and Empagliflozin in the Blood When Taken Separately and Together

Launched by BOEHRINGER INGELHEIM · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how two medicines, vicadrostat and empagliflozin, behave in the body when taken alone compared to when taken together. The goal is to see if taking these medicines together changes the amount that gets into the blood, which helps researchers understand how they might work when combined.

The study is looking for healthy men between the ages of 18 and 55 who have a body weight within a healthy range. Before joining, participants will have a full health check, including blood pressure, heart rate, an ECG (which records the heart’s electrical activity), and lab tests to make sure they are healthy. If accepted, participants will take the medicines either separately or together, and their blood will be tested to measure the levels of each drug. This study is not yet recruiting, and it focuses on safety and how the body processes these medicines, so people taking part can expect careful monitoring throughout the trial.

Gender

MALE

Eligibility criteria

• 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 exclusion criteria apply.