A Study in Healthy People to Test How 2 Different Formulations of a Combination Treatment (Vicadrostat and Empagliflozin) Are Taken up in the Body and How Food Influences the Amount of the Medicines in the Blood

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: vicadrostat / empagliflozin combination 1; Drug: vicadrostat / empagliflozin 2

• Registration Number: NCT07133399
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the relative bioavailability of two different vicadrostat/empagliflozin combinations. Additionally, the trial investigates the effect of food on the pharmacokinetics of the vicadrostat/empagliflozin.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Study Start: 2025-09-05
• Primary Completion: 2025-10-22
• Study Completion: 2025-10-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

1. Any finding in the medical examination (including Blood pressure (BP) Pulse rate (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 45 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
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 exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
R -T1 -T2	vicadrostat / empagliflozin combination 1	R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed
R -T1 -T2	vicadrostat / empagliflozin 2	R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed
T1 - R - T2	vicadrostat / empagliflozin combination 1	R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed
T1 - R - T2	vicadrostat / empagliflozin 2	R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)	Up to 4 days
Maximum measured concentration of the analyte in plasma (C max)	Up to 4 days

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)	Up to 4 days

Trial Locations

Locations (1)

CRS Clinical Research Services Mannheim GmbH; 🇩🇪 Mannheim, Germany