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Completed

NCT Number: NCT07513207

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

  • 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
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Treatment and study plan

Vicadrostat

Drug

Vicadrostat

Placebo matching vicadrostat

Drug

Placebo matching Vicadrostat

moxifloxacin

Drug

Moxifloxacin

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

    Time frame: at baseline, up to 24 hours

    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

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

    Time frame: at baseline, up to 24 hours

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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