Vicadrostat effects on the heart in healthy adults

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)

This trial will test whether vicadrostat changes heart electrical activity or rhythm compared with placebo and a positive control in healthy men and women aged 18 to 50.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Biberach)
• Trial ID: NCT07513207 on ClinicalTrials.gov

What this trial studies

This Phase 1 study enrolls healthy adult volunteers to receive vicadrostat, a matching placebo, and moxifloxacin as a positive control so investigators can compare cardiac effects. Participants will undergo serial 12-lead ECGs, vital sign monitoring, and clinical laboratory tests to detect any drug-related changes in cardiac conduction or rhythm. Eligibility is determined by medical history, physical exam, ECG, and labs, and participants must meet the specified age and BMI ranges. Findings will guide safety and dosing decisions for later clinical development.

Who should consider this trial

Good fit: Healthy adults aged 18 to 50 with BMI 18.5–29.9 kg/m², normal ECGs and laboratory results, and no clinically relevant medical findings are the intended participants.

Not a fit: People with existing heart disease, abnormal ECGs, out-of-range blood pressure or pulse, abnormal labs, or those outside the age or BMI limits are unlikely to benefit from or qualify for this study.

Why it matters

Potential benefit: If vicadrostat does not adversely affect the heart, it could proceed to later trials with greater confidence about cardiac safety.

How similar studies have performed: Similar healthy-volunteer cardiac safety studies using moxifloxacin as a positive control are a well-established approach and have successfully characterized cardiac effects for many investigational drugs.

Eligibility criteria

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.

Where this trial is running

Biberach

• Humanpharmakologisches Zentrum Biberach — Biberach, Germany (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy