NCT07035457

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

July 2, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

June 17, 2025

Last Update Submit

August 19, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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)

Study Arms (3)

Treatment sequence A: R1-R2-T

EXPERIMENTAL

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

Drug: VicadrostatDrug: Jardiance®

Treatment sequence B: R2-T-R1

EXPERIMENTAL

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

Drug: VicadrostatDrug: Jardiance®

Treatment sequence C: T-R1-R2

EXPERIMENTAL

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

Drug: VicadrostatDrug: Jardiance®

Interventions

VicadrostatDRUG

Vicadrostat

Also known as: BI 690517
Treatment sequence A: R1-R2-TTreatment sequence B: R2-T-R1Treatment sequence C: T-R1-R2
Jardiance®DRUG

Jardiance®

Also known as: Empagliflozin
Treatment sequence A: R1-R2-TTreatment sequence B: R2-T-R1Treatment sequence C: T-R1-R2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

MeSH Terms

Interventions

empagliflozin

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

July 2, 2025

Primary Completion

August 7, 2025

Study Completion

August 15, 2025

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Locations

DE(1)