A Study in Healthy People to Test How Vicadrostat Affects the Heart

Thorough QT Study to Evaluate the Effects of Single Doses of Vicadrostat on Cardiac Safety Parameters in Healthy Male and Female Subjects (a Randomized, Placebo-controlled, Double-blind, Five-period Crossover Study With Open-label Moxifloxacin as Positive Control)

The main objective of this trial is to investigate the effect of vicadrostat on the heart compared with placebo in healthy male and female volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Moxifloxacin; Drug: Vicadrostat; Drug: Placebo matching Vicadrostat

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany, 88397
    • Humanpharmakologisches Zentrum Biberach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. 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 (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 50 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria:

1. Any finding in the medical examination (including BP, 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 Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment 1 - vicadrostat low dose	Drug: Vicadrostat; Vicadrostat
Experimental: Treatment 2 - vicadrostat high dose	Drug: Vicadrostat; Vicadrostat
Active Comparator: Treatment 3 - moxifloxacin	Drug: Moxifloxacin; Moxifloxacin
Placebo Comparator: Treatment 4 - placebo	Drug: Placebo matching Vicadrostat; Placebo matching Vicadrostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum mean difference between each single dose of either low or high dose of vicadrostat and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration	QT interval is the electrocardiogram (ECG) interval from the start of the QRS complex to the end of the T wave QTcF: QT interval corrected for heart rate using the method of Fridericia	at baseline, up to 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
The maximum mean difference between moxifloxacin and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration	at baseline, up to 24 hours

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2026
• Primary Completion (Actual): July 24, 2026
• Study Completion (Actual): August 21, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin
• Other Study ID Numbers: 1378-0027; 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk); 2025-524106-14-00 (Ctis); U1111-1318-1618 (Registry Identifier: WHO - International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No