Can a new drug keep the Heart's beat steady? trial puts verducatib to the test
NCT ID NCT07760246
First seen Aug 12, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This Phase 1 trial is testing whether an experimental drug called verducatib affects the heart's electrical activity, specifically the QT interval, which is a measure of heart rhythm safety. Healthy adults aged 18 to 50 will receive multiple doses of verducatib, a placebo, or moxifloxacin (a drug known to affect the QT interval) to compare effects. The study uses ECG monitoring and blood samples to see if verducatib changes heart rhythm compared to placebo, with moxifloxacin serving as a reference to validate the methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Verducatib (BI 1291583), an experimental drug, compared against placebo and moxifloxacin (a known heart-rhythm-affecting antibiotic used as a positive control).
- What this could lead to
- If verducatib shows no significant heart-rhythm effects, it could support its safe development as a future treatment.
- What could go wrong
- This is an early Phase 1 trial in healthy volunteers, so results may not predict effects in patients. The drug could still affect heart rhythm, which would limit its use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy male and female trial participants 2. Aged 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 blood pressure (BP), heart rate (HR) or electrocardiogram (ECG), deviating from normal and assessed as clinically relevant by the Investigator 2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or pulse rate (PR) outside the range of 50 to 90 bpm 3. Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance, including but not limited to increased hepatic parameters, electrolyte disturbances, particularly hypokalemia and hypomagnesemia 4. Any evidence of a concomitant disease assessed as clinically relevant by the Investigator Further exclusion criteria apply.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CRS Clinical Research Services Mannheim GmbH
RECRUITINGMannheim, 68167, Germany
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