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

NCT05380947 | Completed Phase 1 Results

• 2 other identifiers: 1479-00032022-000268-23
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• 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 %.

  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 %.

  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-∞)

  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.

Study Arms (4)

Treatment sequence 1: R - T1 - T2 - T3

EXPERIMENTAL

Treatments: R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole

Drug: BI 1810631 - trial formulation 1 (TF1); Drug: BI 1810631 - new formulation (NF); Drug: Rabeprazole sodium

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

Interventions

BI 1810631 - trial formulation 1 (TF1) DRUG

BI 1810631 - trial formulation 1 (TF1)

Also known as: Zongertinib,, Hernexeos®

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) DRUG

BI 1810631 - new formulation (NF)

Also known as: Zongertinib,, Hernexeos®

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 sodium DRUG

Rabeprazole sodium

Also known as: Pariet®

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

18002430127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4-way crossover

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: June 23, 2022
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)