Skip to main content
OpenTrials
Completed

NCT Number: NCT07035457

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

The main objective of this trial is to investigate the relative bioavailability of vicadrostat and empagliflozin when administered in combination or individually.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vicadrostat

Drug

Vicadrostat

Other names: BI 690517

JARDIANCE®

Drug

Jardiance®

Other names: Empagliflozin

Primary outcomes

  1. Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3)

  2. Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4)

  3. Maximum measured concentration of vicadrostat in plasma (Cmax)

    Time frame: Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3)

  4. Maximum measured concentration of empagliflozin in plasma (Cmax)

    Time frame: Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4)

Secondary outcomes

  1. Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz )

    Time frame: Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3)

  2. Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    Time frame: Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of Single Doses of Vicadrostat and Empagliflozin Administered Alone Compared to Combined Administration to Healthy Male Subjects (an Open Label, Randomised, Three-way Crossover Trial)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.