Healthy
Conditions
Brief summary
To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg BI 1356 tablet administered as a single dose
Interventions
DRUGBI 1356
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Area under the concentration-time curve of BI 1356 in plasma at different time points | 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 |
| Apparent clearance of BI 1356 in the plasma after extravascular administration (CL/F) | 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 |
Outcome results
None listed