Status:
COMPLETED
Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02183467
Start Date
January 1 2008
Last Update
July 8 2014
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