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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 1810631 - trial formulation 1 (TF1)
* Drug: BI 1810631 - new formulation (NF)
* Drug: Rabeprazole sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 4-way crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment sequence 1: R - T1 - T2 - T3<br>Treatments: R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole | Drug: BI 1810631 - trial formulation 1 (TF1)<br>* BI 1810631 - trial formulation 1 (TF1)<br>Drug: BI 1810631 - new formulation (NF)<br>* BI 1810631 - new formulation (NF)<br>Drug: Rabeprazole sodium<br>* Rabeprazole sodium<br>* Other names: Pariet®;|
| Experimental: Treatment sequence 2: T1 - T3 - R - T2<br> | Drug: BI 1810631 - trial formulation 1 (TF1)<br>* BI 1810631 - trial formulation 1 (TF1)<br>Drug: BI 1810631 - new formulation (NF)<br>* BI 1810631 - new formulation (NF)<br>Drug: Rabeprazole sodium<br>* Rabeprazole sodium<br>* Other names: Pariet®;|
| Experimental: Treatment sequence 3: T2 - R - T3 - T1<br> | Drug: BI 1810631 - trial formulation 1 (TF1)<br>* BI 1810631 - trial formulation 1 (TF1)<br>Drug: BI 1810631 - new formulation (NF)<br>* BI 1810631 - new formulation (NF)<br>Drug: Rabeprazole sodium<br>* Rabeprazole sodium<br>* Other names: Pariet®;|
| Experimental: Treatment sequence 4: T3 - T2 - T1 - R<br> | Drug: BI 1810631 - trial formulation 1 (TF1)<br>* BI 1810631 - trial formulation 1 (TF1)<br>Drug: BI 1810631 - new formulation (NF)<br>* BI 1810631 - new formulation (NF)<br>Drug: Rabeprazole sodium<br>* Rabeprazole sodium<br>* Other names: Pariet®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | up to 6 days | 
| Maximum measured concentration of BI 1810631 in plasma (Cmax) |  | up to 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) |  | up to 6 days |