HealthyPhase 1NCT05380947

A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood

A Phase 1 study testing BI 1810631 - trial formulation 1 (TF1), BI 1810631 - new formulation (NF) and Rabeprazole sodium in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 1810631 - trial formulation 1 (TF1), BI 1810631 - new formulation (NF) and Rabeprazole sodium
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteGermany
Study dates: 23 Jun 2022to 13 Sep 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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 45 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 weight divided by height squared (kg/m2) (inclusive)
Signed and dated written informed consent in accordance with International Council on 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 (BP), pulse rate (PR) or electrocardiogram (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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (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)

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Relative Bioavailability of BI 1810631 as Two Different Oral Formulations Given as Single Doses and Investigation of the Effects of Food and Multiple-dose Rabeprazole on the Pharmacokinetics of Single-dose BI 1810631 Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Four-way Crossover Trial)

BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market. This trial intends to bridge pharmacokinetics (PK) between the two formulation principles. For this, relative bioavailability of TF1 and new formulation (NF) is assessed. Moreover the trial intends to inform on the effect of food and of the proton pump inhibitor rabeprazole on the PK of BI 1810631 after administration as NF in order to inform management of food and concomitant medications.

Conditions: Healthy
Being tested: BI 1810631 - trial formulation 1 (TF1), BI 1810631 - new formulation (NF), Rabeprazole sodium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 1810631 - trial formulation 1 (TF1)Drug
Also called Zongertinib,, Hernexeos®
BI 1810631 - trial formulation 1 (TF1)
BI 1810631 - new formulation (NF)Drug
Also called Zongertinib,, Hernexeos®
BI 1810631 - new formulation (NF)
Rabeprazole sodiumDrug
Also called Pariet®
Rabeprazole sodium

Study groups in NCT05380947
Study group	Role	What they receive
Treatment sequence 1: R - T1 - T2 - T3	Experimental	Treatments: R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole Receives: Drug: BI 1810631 - trial formulation 1 (TF1); Drug: BI 1810631 - new formulation (NF); Drug: Rabeprazole sodium
Treatment sequence 2: T1 - T3 - R - T2	Experimental	Not described Receives: Drug: BI 1810631 - trial formulation 1 (TF1); Drug: BI 1810631 - new formulation (NF); Drug: Rabeprazole sodium
Treatment sequence 3: T2 - R - T3 - T1	Experimental	Not described Receives: Drug: BI 1810631 - trial formulation 1 (TF1); Drug: BI 1810631 - new formulation (NF); Drug: Rabeprazole sodium
Treatment sequence 4: T3 - T2 - T1 - R	Experimental	Not described Receives: Drug: BI 1810631 - trial formulation 1 (TF1); Drug: BI 1810631 - new formulation (NF); Drug: Rabeprazole sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) was reported.
Unit of geometric coefficient of variation (gCV) is %.
Measured: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.
Maximum Measured Concentration of BI 1810631 in Plasma (Cmax)
The maximum measured concentration of BI 1810631 in plasma (Cmax) was reported.
Unit of geometric coefficient of variation (gCV) is %.
Measured: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.

Secondary outcomes (1)

Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) was reported.
Unit of geometric coefficient of variation (gCV) is %.
Measured: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 202213 Sep 2022

First posted19 May 2022
Study start23 Jun 2022
Primary completion13 Sep 2022
Study completion13 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Model description: 4-way crossover
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05380947
Sponsor's protocol ID: 1479-0003
Other IDs: 2022-000268-23
Status last verified: Oct 2025
First submitted: 16 May 2022
Last updated: 4 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
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.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of BI 1810631 as Two Different Oral Formulations Given as Single Doses and Investigation of the Effects of Food and Multiple-dose Rabeprazole on the Pharmacokinetics of Single-dose BI 1810631 Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Four-way Crossover Trial)
ClinicalTrials.gov ID: NCT05380947
Acronym / sponsor ID: 1479-0003
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 23 Jun 2022 (actual)
Primary completion: 13 Sep 2022 (actual)
Study completion: 13 Sep 2022 (actual)
First posted: 19 May 2022 (actual)
Results: Posted 4 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: 4-way crossover

Arm	Type	Receives
Treatment sequence 1: R - T1 - T2 - T3	Experimental	Drug: BI 1810631 - trial formulation 1 (TF1), Drug: BI 1810631 - new formulation (NF), Drug: Rabeprazole sodiumTreatments: R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole
Treatment sequence 2: T1 - T3 - R - T2	Experimental	Drug: BI 1810631 - trial formulation 1 (TF1), Drug: BI 1810631 - new formulation (NF), Drug: Rabeprazole sodium
Treatment sequence 3: T2 - R - T3 - T1	Experimental	Drug: BI 1810631 - trial formulation 1 (TF1), Drug: BI 1810631 - new formulation (NF), Drug: Rabeprazole sodium
Treatment sequence 4: T3 - T2 - T1 - R	Experimental	Drug: BI 1810631 - trial formulation 1 (TF1), Drug: BI 1810631 - new formulation (NF), Drug: Rabeprazole sodium

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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 45 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 weight divided by height squared (kg/m2) (inclusive)
Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Key exclusion criteria (9 listed)

Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (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

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
BI 1810631 - trial formulation 1 (TF1)Also: Zongertinib,, Hernexeos®BI 1810631 - trial formulation 1 (TF1)	Drug	Treatment sequence 1: R - T1 - T2 - T3, Treatment sequence 2: T1 - T3 - R - T2, Treatment sequence 3: T2 - R - T3 - T1, Treatment sequence 4: T3 - T2 - T1 - R
BI 1810631 - new formulation (NF)Also: Zongertinib,, Hernexeos®BI 1810631 - new formulation (NF)	Drug	Treatment sequence 1: R - T1 - T2 - T3, Treatment sequence 2: T1 - T3 - R - T2, Treatment sequence 3: T2 - R - T3 - T1, Treatment sequence 4: T3 - T2 - T1 - R
Rabeprazole sodiumAlso: Pariet®Rabeprazole sodium	Drug	Treatment sequence 1: R - T1 - T2 - T3, Treatment sequence 2: T1 - T3 - R - T2, Treatment sequence 3: T2 - R - T3 - T1, Treatment sequence 4: T3 - T2 - T1 - R

Primary outcome

Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.
The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) was reported. Unit of geometric coefficient of variation (gCV) is %.
Maximum Measured Concentration of BI 1810631 in Plasma (Cmax)
Time frame: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.
The maximum measured concentration of BI 1810631 in plasma (Cmax) was reported. Unit of geometric coefficient of variation (gCV) is %.

1 secondary outcome

Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.

Results and safety

Results posted to the registry on 4 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 1: R - T1 - T2 - T3	3	3
Treatment Sequence 2: T1 - T3 - R - T2	4	4
Treatment Sequence 3: T2 - R - T3 - T1	3	3
Treatment Sequence 4: T3 - T2 - T1 - R	3	3

Primary outcome: Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.. Geometric mean (Geometric Coefficient of Variation). Unit: hour * nanomole / Liter (h*nmol/L)

Measure	TF1 Fasted (R) n = 12	NF Fasted (T1) n = 12	NF Fed (T2) n = 9	NF Fasted + Rabeprazole (T3) n = 11
Value	4240 (52.7)	5680 (18.8)	4060 (13.7)	5410 (27.6)

TF1 Fasted (R) vs NF Fasted (T1): Adjusted geometric means ratio (T1/R): 135.2 (90% CI 99.7 to 183.6)
NF Fasted (T1) vs NF Fed (T2): Adjusted geometric means ratio (T2/T1): 74.2 (90% CI 67.6 to 81.6)
NF Fasted (T1) vs NF Fasted + Rabeprazole (T3): Adjusted geometric means ratio (T3/T1): 97.1 (90% CI 85.8 to 110.0)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.

Primary outcome: Maximum Measured Concentration of BI 1810631 in Plasma (Cmax)

Measure	TF1 Fasted (R) n = 12	NF Fasted (T1) n = 12	NF Fed (T2) n = 9	NF Fasted + Rabeprazole (T3) n = 11
Value	291 (93.1)	399 (37.3)	208 (31.4)	327 (34.2)

TF1 Fasted (R) vs NF Fasted (T1): Adjusted geometric means ratio (T1/R): 139.3 (90% CI 87.7 to 221.3)
NF Fasted (T1) vs NF Fed (T2): Adjusted geometric means ratio (T2/T1): 53.5 (90% CI 40.5 to 70.8)
NF Fasted (T1) vs NF Fasted + Rabeprazole (T3): Adjusted geometric means ratio (T3/T1): 87.0 (90% CI 66.8 to 113.2)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TF1 Fasted (R)	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
NF Fasted (T1)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
NF Fed (T2)	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
Rabeprazole	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
NF Fasted + Rabeprazole (T3)	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.mystudywindow.com/msw/datatransparency

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 BI 1810631 - trial formulation 1 (TF1), BI 1810631 - new formulation (NF) and Rabeprazole sodium 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 9 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: finished, as of the sponsor's last update on 4 Nov 2025. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.). 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?

On the ClinicalTrials.gov record for NCT05380947.

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 4 Nov 2025.