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Will a common seizure drug alter the fate of an experimental medicine?

NCT ID NCT07781631

Knowledge-focused Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This phase 1 trial is testing whether carbamazepine, a drug that speeds up liver enzymes, changes how the body absorbs and clears verducatib, an experimental medicine. Healthy male volunteers aged 18 to 50 will take verducatib alone, then with carbamazepine, to compare drug levels in the blood. The goal is to understand potential interactions that could affect dosing in future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
verducatib (also called BI 1291583) and carbamazepine
What this could lead to
If carbamazepine changes how verducatib is processed, it could help guide safe dosing of verducatib in future patients who also take carbamazepine.
What could go wrong
This is a small, early-phase study in healthy volunteers, not patients, so results may not reflect real-world use. Carbamazepine can cause side effects like dizziness or liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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) 2. Age of 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 international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial Exclusion Criteria: 1. 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 2. 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 3. 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 4. Any evidence of a concomitant disease assessed as clinically relevant by the Investigator 5. Further exclusion criteria apply

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • CRS Clinical Research Services Berlin GmbH

    Berlin, 13627, Germany

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