Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects

Study Overview
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Brief Summary
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Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male subjects as well as to investigate pharmacokinetics, safety and tolerability

Official Title
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Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 1060469
* Drug: BI 1060469
* Drug: Other: standard breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: healthy male according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests Age of 18 to 50 years (incl.) Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.) Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation Exclusion criteria: Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator Repeated measurement of systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening Serum creatinine laboratory value outside the normal range estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula < 90 ml/ min Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections) Any evidence of a concomitant disease judged as clinically relevant by the investigator Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening Serum creatinine laboratory value outside the normal range estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula < 90 ml/ min Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections) Any evidence of a concomitant disease judged as clinically relevant by the investigator

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 1060469 fed<br>tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administr | Drug: BI 1060469<br>* tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration<br>Drug: Other: standard breakfast<br>* tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration<br>|
| Experimental: BI 1060469 fasted<br>tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h | Drug: BI 1060469<br>* tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) |  | up to 6 days after last drug administration | 
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 6 days after last drug administration | 
| Frequency of subjects with drug-related adverse events |  | up to 7 days after last drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 6 days after last drug administration |