A Study to Test How Well Different Doses of BI 1815368 Are Tolerated by Healthy Men

Study Overview
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Brief Summary
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This trial aims to investigate safety, tolerability, and pharmacokinetics following multiple rising doses of BI 1815368 in healthy male subjects.

Official Title
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Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1815368 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 1815368
* Drug: Matching placebo


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 55 years (inclusive). Body mass index (BMI) of 19 to 29.9 kg/m2 (inclusive). Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Exclusion Criteria: Any finding in the medical examination (including BP, PR 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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 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: 55 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Matching placebo<br>* Matching placebo<br>* Other names: Placebo;|
| Experimental: Dose Group 1: BI 1815368 (Low dose)<br> | Drug: BI 1815368<br>* BI 1815368<br>|
| Experimental: Dose Group 2: BI 1815368 (Low to Medium dose)<br> | Drug: BI 1815368<br>* BI 1815368<br>|
| Experimental: Dose Group 3: BI 1815368 (Medium dose)<br> | Drug: BI 1815368<br>* BI 1815368<br>|
| Experimental: Dose Group 4: BI 1815368 (Medium to High dose)<br> | Drug: BI 1815368<br>* BI 1815368<br>|
| Experimental: Dose Group 5: BI 1815368 (High dose)<br> | Drug: BI 1815368<br>* BI 1815368<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients treated who experience treatment-emergent adverse event assessed as drug-related by the investigator |  | Up to 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of BI 1815368 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) |  | Up to 16 days | 
| Minimum concentration of BI 1815368 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) |  | Up to 16 days | 
| Maximum measured concentration of BI 1815368 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) |  | Up to 16 days |