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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2025-08-15

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment sequence A: R1-R2-T

Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together

Group Type EXPERIMENTAL

Vicadrostat

Intervention Type DRUG

Vicadrostat

Jardiance®

Intervention Type DRUG

Jardiance®

Treatment sequence B: R2-T-R1

Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together

Group Type EXPERIMENTAL

Vicadrostat

Intervention Type DRUG

Vicadrostat

Jardiance®

Intervention Type DRUG

Jardiance®

Treatment sequence C: T-R1-R2

Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together

Group Type EXPERIMENTAL

Vicadrostat

Intervention Type DRUG

Vicadrostat

Jardiance®

Intervention Type DRUG

Jardiance®

Interventions

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Vicadrostat

Intervention Type DRUG

Jardiance®

Intervention Type DRUG

Other Intervention Names

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BI 690517 Empagliflozin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes