Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects

Study Overview
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Brief Summary
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Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval

Official Title
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Assessment of the Effect of 5 mg and 100 mg of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Four-way Crossover Study With Moxifloxacin as Positive Control

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 1356, low dose
* Drug: BI 1356, high dose
* Drug: Placebo
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females, 21 to 50 years of age Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2 Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation Exclusion Criteria: Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders History of orthostatic hypotension, fainting spells or blackouts Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study Participation in another trial with an investigational drug (≤ 60 days prior to administration or during the trial) Heavy smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day) Inability to refrain from smoking on trial days Alcohol abuse (> 60 g/day) Drug abuse Blood donation (≥ 100 mL within four weeks prior to administration or during the trial) Any deviation of a laboratory value that is considered to be of clinical relevance Excessive physical activities within the last week before the trial or during the trial Hypersensitivity to Moxifloxacin or related drugs of these classes Supine blood pressure at screening of systolic < 100 mmHg and diastolic < 60 mmHg Heart rate at screening of > 80 bpm or < 40 bpm Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval > 220 ms, QRS interval > 115 ms, QTcB or QTcF > 450 ms, or QT (uncorrected) > 470 ms Subjects involved in passenger transport or operation of dangerous machines For Female subjects: Pregnancy or positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion Pregnancy No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, IUD [intrauterine device], sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who have not a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide) Lactation period

Ages Eligible for Study
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Minimum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 1356, low dose<br> | Drug: BI 1356, low dose<br> <br> |
| Experimental: BI 1356, high dose<br> | Drug: BI 1356, high dose<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Moxifloxacin<br> | Drug: Moxifloxacin<br> <br> * Other names: Avalox®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the QTcI interval (individually heart rate-corrected QT interval length) |  | Pre-dose and 1 to 4 hours following administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of the QTcI change from baseline of all electrocardiograms (ECGs) taken from 1 hour to 24 hours after dosing |  | up to 24 hours following administration | 
| Change from mean baseline of the QTcI at any point in time between 1 and 24 hours after dosing |  | up to 24 hours following administration |