HealthyPhase 1NCT07781631
A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Verducatib in the Blood
A Phase 1 study testing Verducatib and Carbamazepine in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The main objective of this trial is to investigate the effect of carbamazepine, a strong CYP3A4 inducer on the pharmacokinetics of verducatib at steady state. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Verducatib and Carbamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 10 Sep 2026to 20 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male trial participant according to the assessment of the Investigator, as based on a complete medical history including physical examination, vital signs (blood pressure, heart rate), 12-lead electrocardiogram, clinical laboratory tests and columbia-suicide severity rating scale (C-SSRS)
- Age of 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 international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
Who cannot join
- Any finding in the medical examination, including blood pressure, pulse rate or electrocardiogram, as well as neurological examination and skin inspection deviating from normal and assessed as clinically relevant by the Investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute
- Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance, particularly including but not limited to haematological parameters such as haemoglobin, serum iron, leucocyte- and platelet count, hepatic parameters such as alanine aminotransferase (ALT), aspartate aminotransfrrase (AST), gamma-glutamyl transferase (GGT) and total bilirubin or renal parameters such as e.g. creatinine at screening, electrolyte disturbances, particularly hyponatremia
- 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 Berlin GmbH
Berlin, 13627
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
About this study
Official title: An Open-label, Fixed-sequence, Two-period Phase I Trial to Evaluate the Effect of Multiple Oral Doses of Carbamazepine, a Strong CYP3A4 Inducer, on the Pharmacokinetics of Verducatib at Steady State in Healthy Male Trial Participants
The main objective of this trial is to investigate the effect of carbamazepine, a strong CYP3A4 inducer on the pharmacokinetics of verducatib at steady state.
- Conditions
- Healthy
- Being tested
- Verducatib, Carbamazepine
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
CarbamazepineDrug
Carbamazepine
| Study group | Role | What they receive |
|---|---|---|
| Verducatib, then verducatib + carbamazepine | Experimental | Fixed-sequence treatment for all trial participants. Receives: Drug: Verducatib; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Measured: Up to 40 days.
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Measured: Up to 40 days.
Secondary outcomes (1)
Minimum concentration of the analyte in plasma at steady state within a uniform dosing interval τ (Cmin,ss)
Measured: Up to 40 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start10 Sep 2026
- Primary completion14 Dec 2026 (estimated)
- Study completion20 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants receive verducatib in the treatment period 1 and continue for the treatment period 2 to receive verducatib and carbamazepine.
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07781631
- Sponsor's protocol ID
- 1397-0044
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 23 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence, Two-period Phase I Trial to Evaluate the Effect of Multiple Oral Doses of Carbamazepine, a Strong CYP3A4 Inducer, on the Pharmacokinetics of Verducatib at Steady State in Healthy Male Trial Participants
- ClinicalTrials.gov ID
- NCT07781631
- Acronym / sponsor ID
- 1397-0044
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 24 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 investigate the effect of carbamazepine, a strong CYP3A4 inducer on the pharmacokinetics of verducatib at steady state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants receive verducatib in the treatment period 1 and continue for the treatment period 2 to receive verducatib and carbamazepine.
| Arm | Type | Receives |
|---|---|---|
| Verducatib, then verducatib + carbamazepine | Experimental | Drug: Verducatib, Drug: CarbamazepineFixed-sequence treatment for all trial participants. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male trial participant according to the assessment of the Investigator, as based on a complete medical history including physical examination, vital signs (blood pressure, heart rate), 12-lead electrocardiogram, clinical laboratory tests and columbia-suicide severity rating scale (C-SSRS)
- Age of 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 international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
Key exclusion criteria (5 listed)
- Any finding in the medical examination, including blood pressure, pulse rate or electrocardiogram, as well as neurological examination and skin inspection deviating from normal and assessed as clinically relevant by the Investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute
- Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance, particularly including but not limited to haematological parameters such as haemoglobin, serum iron, leucocyte- and platelet count, hepatic parameters such as alanine aminotransferase (ALT), aspartate aminotransfrrase (AST), gamma-glutamyl transferase (GGT) and total bilirubin or renal parameters such as e.g. creatinine at screening, electrolyte disturbances, particularly hyponatremia
- 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 | Verducatib, then verducatib + carbamazepine |
| CarbamazepineCarbamazepine | Drug | Verducatib, then verducatib + carbamazepine |
Primary outcome
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame: Up to 40 days.
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: Up to 40 days.
1 secondary outcome
Minimum concentration of the analyte in plasma at steady state within a uniform dosing interval τ (Cmin,ss)
Time frame: Up to 40 days.
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 23 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 Carbamazepine 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 5 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 23 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?
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) (time frame: Up to 40 days.). The study lists 2 primary outcomes in all. 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 23 Sep 2026.