NCT07845630

Brief Summary

The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
2mo left

Started Oct 2026

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

September 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

October 14, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2026

10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2026

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

    Up to 4 days.

  • Maximum measured concentration of the analyte in plasma (Cmax)

    Up to 4 days.

Secondary Outcomes (1)

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

    Up to 4 days.

Study Arms (2)

Reference treatment (R), then Test treatment (T)

EXPERIMENTAL

Vicadrostat + empagliflozin administered at the same time (R), then Vicadrostat + empagliflozin combined (T)

Drug: VicadrostatDrug: EmpagliflozinDrug: Vicadrostat + empagliflozin

Test treatment (T), Reference treatment (R)

EXPERIMENTAL

Vicadrostat + empagliflozin combined (T), then Vicadrostat + empagliflozin administered at the same time (R)

Drug: VicadrostatDrug: EmpagliflozinDrug: Vicadrostat + empagliflozin

Interventions

VicadrostatDRUG

Vicadrostat

Reference treatment (R), then Test treatment (T)Test treatment (T), Reference treatment (R)
EmpagliflozinDRUG

Empagliflozin

Also known as: Jardiance®
Reference treatment (R), then Test treatment (T)Test treatment (T), Reference treatment (R)
Vicadrostat + empagliflozinDRUG

Vicadrostat + empagliflozin combined

Reference treatment (R), then Test treatment (T)Test treatment (T), Reference treatment (R)

Eligibility Criteria

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

You may qualify if:

  • Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electrocardiogram, and clinical laboratory tests
  • Age of 18 to 55 years (inclusive)
  • Body mass index 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 and local legislation prior to admission to the trial

You may not qualify if:

  • Any finding in the medical examination (including Blood pressure, Pulse rate or Electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
  • 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
  • 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

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

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

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

September 23, 2026

First Posted

September 29, 2026

Study Start (Estimated)

October 14, 2026

Primary Completion (Estimated)

December 11, 2026

Study Completion (Estimated)

December 21, 2026

Last Updated

September 29, 2026

Record last verified: 2026-09

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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Locations

DE(1)