Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers

Study Overview
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Brief Summary
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To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.

Official Title
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Open, Randomised, Two-way Crossover Study to Assess the Effect of a High Fat, High Caloric Meal on the Pharmacokinetics of BI 409306, Followed by a Fixed Sequence Period to Investigate the Pharmacokinetics of BI 409306 After a Single Oral Dose Given at Bed Time in Healthy Male and Female Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 409306
* Drug: BI 409306
* Drug: BI 409306


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male and female volunteers Age 18 (incl.) to 50 (incl.) years Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2 Exclusion criteria: Any evidence of a clinically relevant concomitant disease Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of the gastrointestinal tract (except appendectomy) Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis. Positive pregnancy test No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

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: 1 BI 409306<br>tablet, fasted, oral administration with 240 ml water | Drug: BI 409306<br>* medium dose, oral administration<br>|
| Experimental: 2 BI 409306<br>tablet, fed, oral administration with 240 ml water | Drug: BI 409306<br>* medium dose, oral administration<br>|
| Experimental: 3 BI 409306<br>tablet, oral administration with 240 ml water at bed time | Drug: BI 409306<br>* medium dose, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | 8 weeks | 
| AUC0-tz (area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point) |  | 8 weeks | 

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) |  | 8 weeks |