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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Fluoroquinolones; Linagliptin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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