A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body

Study Overview
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Brief Summary
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This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet formulation for oral administration, using an intravenous microtracer approach with [14C]-labelled BI 1015550. These data are considered necessary to further support the understanding of the pharmacokinetics of BI 1015550.

Official Title
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Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 1015550 Administered as an Oral Dose With an Intravenous Microtracer Dose of [14C]-BI 1015550 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 1015550
* Drug: BI 1015550 mixed with [C-14]-BI 1015550


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 65 years (inclusive) Body mass index (BMI) of 18.5 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 40 to 100 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 (including but not limited to major depressive disorder or history of suicide attempts) 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: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test treatment (T) followed by Reference treatment (R)<br> | Drug: BI 1015550<br>* Treatment T<br>Drug: BI 1015550 mixed with [C-14]-BI 1015550<br>* Treatment R<br>|

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 [14C]-BI 1015550 in plasma after intravenous (i.v.) administration over the time interval from 0 to infinity (AUC0-∞) |  | up to 10 days | 
| Area under the concentration-time curve of BI 1015550 in plasma after oral (p.o.) administration over the time interval from 0 to infinity (AUC0-∞) |  | up to 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum measured concentration of BI 1015550 in plasma after oral (p.o.) administration (Cmax) |  | up to 8 days |