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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02183467
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1356, low dose Drug: BI 1356, high dose Drug: Placebo Drug: Moxifloxacin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BI 1356, low dose Drug: BI 1356, low dose
Experimental: BI 1356, high dose Drug: BI 1356, high dose
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Moxifloxacin Drug: Moxifloxacin
Other Name: Avalox®

Primary Outcome Measures :
  1. Change from baseline of the QTcI interval (individually heart rate-corrected QT interval length) [ Time Frame: Pre-dose and 1 to 4 hours following administration ]

Secondary Outcome Measures :
  1. Mean of the QTcI change from baseline of all electrocardiograms (ECGs) taken from 1 hour to 24 hours after dosing [ Time Frame: up to 24 hours following administration ]
  2. Change from mean baseline of the QTcI at any point in time between 1 and 24 hours after dosing [ Time Frame: up to 24 hours following administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Responsible Party: Boehringer Ingelheim Identifier: NCT02183467    
Other Study ID Numbers: 1218.32
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hypoglycemic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors