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

NCT07513207 | Active Not Recruiting Phase 1

• 3 other identifiers: 1378-00272025-524106-14-00U1111-1318-1618
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

Treatment 1 - vicadrostat low dose

EXPERIMENTAL

Drug: Vicadrostat

Treatment 2 - vicadrostat high dose

EXPERIMENTAL

Drug: Vicadrostat

Treatment 3 - moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Treatment 4 - placebo

PLACEBO COMPARATOR

Drug: Placebo matching Vicadrostat

Interventions

Placebo matching Vicadrostat DRUG

Placebo matching Vicadrostat

Treatment 4 - placebo

Moxifloxacin DRUG

Moxifloxacin

Treatment 3 - moxifloxacin

Vicadrostat DRUG

Vicadrostat

Treatment 1 - vicadrostat low dose; Treatment 2 - vicadrostat high dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 50 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 7, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): August 21, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)