HealthyPhase 1NCT07789028
A Study in Healthy People to Test How Zongertinib is Taken up in the Body When Given as Tablets Made by Two Different Manufacturers With or Without Food
A Phase 1 study testing Zongertinib, Formulation A, reference product and Zongertinib Formulation B, test product in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration. 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?
- Zongertinib, Formulation A, reference product and Zongertinib Formulation B, test product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2026to 21 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 or female trial participant 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 50 years (inclusive)
- Body mass index 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 and local legislation prior to admission to the trial
- Further inclusion criteria apply.
Who cannot join
- Any finding in the medical examination (including BP, PR rate or ECG) 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 45 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
- 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
Humanpharmakologisches Zentrum Biberach
Biberach, 88397
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
About this study
Official title: Bioequivalence of Zongertinib Tablets From Two Different Manufacturers Following Oral Administration in Healthy Male and Female Trial Participants in Fasted and Fed State (an Open-label, Randomised, Single-dose, Four-period, Four-sequence Crossover Trial)
The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.
- Conditions
- Healthy
- Being tested
- Zongertinib, Formulation A, reference product, Zongertinib Formulation B, test product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zongertinib, Formulation A, reference productDrug
Also called BI 1810631
Zongertinib, Formulation A, reference product
Zongertinib Formulation B, test productDrug
Also called BI 1810631
Zongertinib Formulation B, test product
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Experimental | Test product, fasted condition Reference product, fasted condition Test product, fed condition Reference product, fed condition Receives: Drug: Zongertinib, Formulation A, reference product; Drug: Zongertinib Formulation B, test product |
| Treatment sequence 2 | Experimental | Reference product, fasted condition Reference product, fed condition Test product, fasted condition Test product, fed condition Receives: Drug: Zongertinib, Formulation A, reference product; Drug: Zongertinib Formulation B, test product |
| Treatment sequence 3 | Experimental | Test product, fed condition Test product, fasted condition Reference product, fed condition Reference product, fasted condition Receives: Drug: Zongertinib, Formulation A, reference product; Drug: Zongertinib Formulation B, test product |
| Treatment sequence 4 | Experimental | Reference product, fed condition Test product, fed condition Reference product, fasted condition Test product, fasted condition Receives: Drug: Zongertinib, Formulation A, reference product; Drug: Zongertinib Formulation B, test product |
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 over the time interval from 0-72h (AUC0-72h)
Measured: up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to 4 days
Secondary outcomes (1)
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start9 Sep 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion21 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
- Crossover
- Masking
- None (open label)
- 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
- NCT07789028
- Sponsor's protocol ID
- 1479-0067
- Other IDs
- U1111-1335-5272, 2026-525696-77
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 15 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Zongertinib Tablets From Two Different Manufacturers Following Oral Administration in Healthy Male and Female Trial Participants in Fasted and Fed State (an Open-label, Randomised, Single-dose, Four-period, Four-sequence Crossover Trial)
- ClinicalTrials.gov ID
- NCT07789028
- Acronym / sponsor ID
- 1479-0067
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 27 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 establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Experimental | Drug: Zongertinib, Formulation A, reference product, Drug: Zongertinib Formulation B, test productTest product, fasted condition Reference product, fasted condition Test product, fed condition Reference product, fed condition |
| Treatment sequence 2 | Experimental | Drug: Zongertinib, Formulation A, reference product, Drug: Zongertinib Formulation B, test productReference product, fasted condition Reference product, fed condition Test product, fasted condition Test product, fed condition |
| Treatment sequence 3 | Experimental | Drug: Zongertinib, Formulation A, reference product, Drug: Zongertinib Formulation B, test productTest product, fed condition Test product, fasted condition Reference product, fed condition Reference product, fasted condition |
| Treatment sequence 4 | Experimental | Drug: Zongertinib, Formulation A, reference product, Drug: Zongertinib Formulation B, test productReference product, fed condition Test product, fed condition Reference product, fasted condition Test product, fasted condition |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female trial participant 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 50 years (inclusive)
- Body mass index 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 and local legislation prior to admission to the trial
- Further inclusion criteria apply.
Key exclusion criteria (5 listed)
- Any finding in the medical examination (including BP, PR rate or ECG) 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 45 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
- 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 |
|---|---|---|
| Zongertinib, Formulation A, reference productAlso: BI 1810631Zongertinib, Formulation A, reference product | Drug | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4 |
| Zongertinib Formulation B, test productAlso: BI 1810631Zongertinib Formulation B, test product | Drug | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4 |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0-72h (AUC0-72h)
Time frame: up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 4 days
1 secondary outcome
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
Time frame: up to 4 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 15 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 Zongertinib, Formulation A, reference product and Zongertinib Formulation B, test product 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 5 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 15 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 over the time interval from 0-72h (AUC0-72h) (time frame: up to 4 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 15 Sep 2026.