NCT07760246

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
5mo left

Started Aug 2026

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

August 17, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2026

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Healthy

Outcome Measures

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

    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

    Up to day 31

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

    Up to day 31

Study Arms (3)

Moxifloxacin placebo followed by Verducatib followed by Moxifloxacin placebo

EXPERIMENTAL
Drug: VerducatibDrug: Placebo resembling Moxifloxacin

Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo

EXPERIMENTAL
Drug: MoxifloxacinDrug: Placebo resembling VerducatibDrug: Placebo resembling Moxifloxacin

Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin

EXPERIMENTAL
Drug: MoxifloxacinDrug: Placebo resembling VerducatibDrug: Placebo resembling Moxifloxacin

Interventions

VerducatibDRUG

Verducatib

Also known as: BI 1291583
Moxifloxacin placebo followed by Verducatib followed by Moxifloxacin placebo
MoxifloxacinDRUG

Moxifloxacin

Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placeboMoxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin
Placebo resembling VerducatibDRUG

Placebo resembling Verducatib

Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placeboMoxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin
Placebo resembling MoxifloxacinDRUG

Placebo resembling Moxifloxacin

Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placeboMoxifloxacin placebo followed by Verducatib followed by Moxifloxacin placeboMoxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Links

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start (Estimated)

August 17, 2026

Primary Completion (Estimated)

December 16, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Locations

DE(1)