RecruitingPhase 1NCT07513207

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)

Sponsor

Boehringer Ingelheim

Enrollment

45 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

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)

Exclusion Criteria3

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

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