Clinical trial NCT02183467: Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of the QTcI interval (individually heart rate-corrected QT interval length)
timeFrame: Pre-dose and 1 to 4 hours following administration
Secondary outcomes:
measure: Mean of the QTcI change from baseline of all electrocardiograms (ECGs) taken from 1 hour to 24 hours after dosing
timeFrame: up to 24 hours following administration
measure: Change from mean baseline of the QTcI at any point in time between 1 and 24 hours after dosing
timeFrame: up to 24 hours following administration
Other outcomes:
Locations:
Study officials:
References: