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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1356, high dose; Drug: BI 1356, low dose; Drug: Placebo; Drug: Moxifloxacin

• Registration Number: NCT02183467
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Last Update Submitted: 2014-07-04
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 1356, high dose	BI 1356, high dose	-
BI 1356, low dose	BI 1356, low dose	-
Placebo	Placebo	-
Moxifloxacin	Moxifloxacin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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