Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects

Study Overview
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Brief Summary
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To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg BI 1356 tablet administered as a single dose

Official Title
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Relative Bioavailability of a 5 mg BI 1356 Tablet Administered With and Without Food to Healthy Male and Female Subjects in an Open, Randomised, Single Dose, Two-way Crossover, Phase I Trial

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 1356


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females according to the following criteria: -- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests Age ≥ 18 and Age ≤ 50 years BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index) Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation Exclusion Criteria: Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg Any evidence of a clinically relevant concomitant disease Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of the gastrointestinal tract (except appendectomy) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders History of relevant orthostatic hypotension, fainting spells or blackouts Chronic or relevant acute infections History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration and during the trial except if a relevant interaction can be ruled out Participation in another trial with an investigational drug within two months prior to first study drug administration or during the trial Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) Inability to refrain from smoking on trial days Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males) Drug abuse Blood donation (more than 100 mL within four weeks prior to the start of study) Excessive physical activities (within one week prior to administration or during the trial) Any laboratory value outside the reference range that is of clinical relevance Inability to comply with dietary regimen of trial site A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms) A history of additional risk factors for torsades de points (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) For female subjects: Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion No adequate contraception during the study and until 2 months after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, intrauterine device (IUD) , sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide) Lactation

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: Fed administration of BI 1356<br> | Drug: BI 1356<br> <br> |
| Active Comparator: Fasted administration of BI 1356<br> | Drug: BI 1356<br> <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 BI 1356 in plasma over the time interval from 0 to 72 h (AUC0-72) |  | up to 72 hours after start of treatment | 
| Maximum measured concentration (Cmax) of BI 1356 in plasma |  | up to 96 hours after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of BI 1356 in plasma at different time points |  | up to 96 hours after start of treatment | 
| Time from dosing to the maximum concentration (tmax) of BI 1356 in plasma |  | up to 96 hours after start of treatment | 
| Terminal elimination rate constant (λz) in plasma |  | up to 96 hours after start of treatment | 
| Terminal half-life (t1/2) of BI 1356 in plasma |  | up to 96 hours after start of treatment | 
| Mean residence time of BI 1356 in the body after oral administration (MRTpo) |  | up to 96 hours after start of treatment | 
| Apparent clearance of BI 1356 in the plasma after extravascular administration (CL/F) |  | up to 96 hours after start of treatment | 
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) |  | up to 96 hours after start of treatment | 
| Number of patients with adverse events |  | up to 11 weeks | 
| Assessment of tolerability on a 4-point scale by investigator |  | 14 days after last study drug administration |