Cure My Disease

Don't miss your cure!

 Log in / Sign up

Drug interaction study reveals how carbamazepine alters zongertinib levels

NCT ID NCT06028464

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 trial in 16 healthy men tested how taking carbamazepine (a strong enzyme inducer) changes the amount of zongertinib in the blood. Participants received a single dose of zongertinib alone, then later took increasing doses of carbamazepine for 18 days followed by another zongertinib dose. The study measured drug levels to see if carbamazepine speeds up zongertinib breakdown, which could affect dosing in future patients.

What this could mean

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

Active substance
Zongertinib and carbamazepine
What this could lead to
If successful, this study could help doctors understand how to adjust zongertinib doses when patients also take carbamazepine.
What could go wrong
This is a small, early-stage trial in healthy volunteers, not patients. Results may not directly apply to people with cancer or other conditions.

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

16 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2023

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 55 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: * Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 55 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 Exclusion Criteria: * Any finding in the medical examination (including BP, PR or ECG, the neurological examination, or the 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 bpm * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * History of relevant orthostatic hypotension, fainting spells, or blackouts * Further exclusion criteria apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

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

Healthy

Contacts and locations

Locations

  • CRS Clinical Research Services Mannheim GmbH

    Mannheim, 68167, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.