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

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: Vicadrostat; Drug: Jardiance®

• Registration Number: NCT07035457
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-07-02
• Primary Completion: 2025-08-07
• Study Completion: 2025-08-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence A: R1-R2-T	Vicadrostat	Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
Treatment sequence A: R1-R2-T	Jardiance®	Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
Treatment sequence B: R2-T-R1	Vicadrostat	Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
Treatment sequence B: R2-T-R1	Jardiance®	Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
Treatment sequence C: T-R1-R2	Vicadrostat	Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
Treatment sequence C: T-R1-R2	Jardiance®	Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany