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NCT Number: NCT07760246

A Study in Healthy People to Measure How Different Doses of Verducatib Affect the Heart

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location contact

Boehringer Ingelheim

CONTACT

[email protected]

08007234742

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female trial participants
  • Aged 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 blood pressure (BP), heart rate (HR) or electrocardiogram (ECG), deviating from normal and assessed as clinically relevant by the Investigator
  • 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
  • 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
  • Any evidence of a concomitant disease assessed as clinically relevant by the Investigator Further exclusion criteria apply.

Treatment and study plan

Verducatib

Drug

Verducatib

Other names: BI 1291583

moxifloxacin

Drug

Moxifloxacin

Placebo resembling Verducatib

Drug

Placebo resembling Verducatib

Placebo resembling Moxifloxacin

Drug

Placebo resembling Moxifloxacin

Primary outcomes

  1. 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 outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 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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