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Completed

NCT Number: NCT05380947

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Exclusion criteria

  • 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
  • further exclusion criteria apply

Treatment and study plan

BI 1810631 - trial formulation 1 (TF1)

Drug

BI 1810631 - trial formulation 1 (TF1)

Other names: Zongertinib,, Hernexeos®

BI 1810631 - new formulation (NF)

Drug

BI 1810631 - new formulation (NF)

Other names: Zongertinib,, Hernexeos®

RABEPRAZOLE SODIUM

Drug

Rabeprazole sodium

Other names: Pariet®

Primary outcomes

  1. 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 %.

  2. 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 %.

Secondary outcomes

  1. 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.

    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 %.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 19, 2022
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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