Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects

Study Overview
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Brief Summary
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The primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects.

Official Title
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Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 691751 fasted
* Drug: BI 691751 after high fat breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogramm (ECG), and clinical laboratory tests Age 18 to 50 years (incl.) Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) Exclusion criteria: Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and 12-lead Electrocardiogramm (ECG)) deviating from normal and judged clinically relevant by the investigator Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Any evidence of a concomitant disease judged clinically relevant by the investigator Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 691751 after high fat breakfast<br>single dose BI 691751 after a standardised high fat breakfast | Drug: BI 691751 after high fat breakfast<br>* single dose BI 691751 after a standardised high fat breakfast<br>|
| Active Comparator: BI 691751 fasted<br>single dose BI 691751 in fasted state | Drug: BI 691751 fasted<br>* single dose BI 691751 in fasted state<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 the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz) |  | up to 480 hours | 
| Maximum measured concentration of the analyte in plasma and whole blood (Cmax) |  | up to 480 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 extrapolated to infinity (AUC0-inf) |  | up to 480 hours |