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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1356, high dose; Drug: Moxifloxacin; Drug: BI 1356, low dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183467

1218.32

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 4 patient groups, including a placebo group

BI 1356, low dose

Experimental group

Treatment:

Drug: BI 1356, low dose

BI 1356, high dose

Experimental group

Treatment:

Drug: BI 1356, high dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin