A Study in Healthy People to Measure How Different Doses of Verducatib Affect the Heart
Healthy
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 1
- Age range
- 18 years - 50 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 56 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The main objective of this trial is to evaluate the effects of verducatib in the range of therapeutic to supra-therapeutic exposures on the QT/QTc-interval and other ECG parameters
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
Moxifloxacin placebo followed by Verducatib followed by Moxifloxacin placebo
Not reported in this registry record.
Drug: Verducatib · Drug: Placebo resembling Moxifloxacin
Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo
Not reported in this registry record.
Drug: Moxifloxacin · Drug: Placebo resembling Verducatib · Drug: Placebo resembling Moxifloxacin
Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin
Not reported in this registry record.
Drug: Moxifloxacin · Drug: Placebo resembling Verducatib · Drug: Placebo resembling Moxifloxacin
Verducatib DRUG
Verducatib
Moxifloxacin DRUG
Moxifloxacin
Placebo resembling Verducatib DRUG
Placebo resembling Verducatib
Placebo resembling Moxifloxacin DRUG
Placebo resembling Moxifloxacin
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
QT-interval corrected for heart rate, e.g. using the method of Fridericia change from baseline (ΔQTcF), paired with the verducatib plasma concentrations
Time frame: Up to day 31
ΔQTcF defined as the time-matched QTcF change from baseline, paired with the verducatib plasma concentrations collected at the same timepoints up to a maximum of 30 days after first drug administration of verducatib/verducatib-placebo
Secondary measures
QT-interval corrected for heart rate, e.g. using the method of Fridericia change from baseline (ΔQTcF), paired with the moxifloxacin plasma concentrations
Time frame: Up to day 31
ΔQTcF, defined as the QTcF change from baseline, paired with the moxifloxacin plasma concentrations collected at the same timepoints up to 24 hours after a single dose administration of moxifloxacin/moxifloxacin-placebo and constitutes the assessment of assay sensitivity in this trial
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
CRS Clinical Research Services Mannheim GmbHMannheim, GermanyStatus unknown
Study team and timeline
- Lead sponsor
- Boehringer Ingelheim
- Study start
- Aug 20, 2026 Actual
- Primary completion
- Dec 30, 2026 Estimated
- Study completion
- Dec 30, 2026 Estimated
- First posted
- Aug 12, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Parallel Group Design Trial With Moxifloxacin as Positive Control in a Nested Crossover to Evaluate the Effects of Multiple Doses of Verducatib (BI 1291583) on Cardiac Safety Parameters in Healthy Male and Female Trial Participants
Ask Wellness Clinical Research
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026