HealthyPhase 1NCT07760246
A Study in Healthy People to Measure How Different Doses of Verducatib Affect the Heart
A Phase 1 study testing Verducatib and Moxifloxacin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Verducatib and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 20 Aug 2026to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
About this study
Official 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
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
- Conditions
- Healthy
- Being tested
- Verducatib, Moxifloxacin, Placebo resembling Verducatib, Placebo resembling Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerducatibDrug
Also called BI 1291583
Verducatib
MoxifloxacinDrug
Moxifloxacin
Placebo resembling VerducatibDrug
Placebo resembling Verducatib
Placebo resembling MoxifloxacinDrug
Placebo resembling Moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin placebo followed by Verducatib followed by Moxifloxacin placebo | Experimental | Not described Receives: Drug: Verducatib; Drug: Placebo resembling Moxifloxacin |
| Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo | Experimental | Not described Receives: Drug: Moxifloxacin; Drug: Placebo resembling Verducatib; Drug: Placebo resembling Moxifloxacin |
| Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin | Experimental | Not described Receives: Drug: Moxifloxacin; Drug: Placebo resembling Verducatib; Drug: Placebo resembling Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Up to day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start20 Aug 2026
- Primary completion16 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760246
- Sponsor's protocol ID
- 1397-0025
- Other IDs
- 2026-525813-30-00, U1111-1335-9069
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07760246
- Acronym / sponsor ID
- 1397-0025
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin placebo followed by Verducatib followed by Moxifloxacin placebo | Experimental | Drug: Verducatib, Drug: Placebo resembling Moxifloxacin |
| Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo | Experimental | Drug: Moxifloxacin, Drug: Placebo resembling Verducatib, Drug: Placebo resembling Moxifloxacin |
| Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin | Experimental | Drug: Moxifloxacin, Drug: Placebo resembling Verducatib, Drug: Placebo resembling Moxifloxacin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerducatibAlso: BI 1291583Verducatib | Drug | Moxifloxacin placebo followed by Verducatib followed by Moxifloxacin placebo |
| MoxifloxacinMoxifloxacin | Drug | Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo, Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin |
| Placebo resembling VerducatibPlacebo resembling Verducatib | Drug | Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo, Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin |
| Placebo resembling MoxifloxacinPlacebo resembling Moxifloxacin | Drug | Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo, Moxifloxacin placebo followed by Verducatib followed by Moxifloxacin placebo, Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Verducatib and Moxifloxacin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.