Last updated on October 2017

This Study Tests BI 1467335 in Healthy Japanese and Caucasian Men. The Study Tests How Different Doses of BI 1467335 Are Taken up in the Body and How Well They Are Tolerated


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy
  • Age: Between 20 - 45 Years
  • Gender: Male
  • Other:
    Healthy male subjects according to the investigator's assessment, based on a complete
    medical history including a physical examination, vital signs (Blood Pressure
    (BP),Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
    Japanese ethnicity or Caucasian, according to the following criteria:
    Japanese; born in Japan, have lived outside of Japan <10 years, and have parents
    and grandparents who were all born in Japan
    Caucasian
    Age of 20 to 45 years (incl.)
    Body Mass Index (BMI) of 18.5 to 25 kg/m2 (incl.) for Japanese and 18.5 to 29.9 kg/m2
    (incl.) for Caucasian
    Signed and dated written informed consent by date of Visit 1 in accordance with Good
    Clinical Practice (GCP) and local legislation.
    Male subjects who agree to minimize the risk of female partners becoming pregnant by
    fulfilling any of the following criteria starting from at least 30 days before the
    first administration of trial medication and until 30 days after trial completion:
    Use of adequate contraception, e.g. any of the following methods plus condom:
    combined oral contraceptives, intrauterine device
    Vasectomised (vasectomy at least 1 year prior to enrolment)
    Surgically sterilised (including hysterectomy) female partner

You may not be eligible for this study if the following are true:

  • Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR)
    or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant
    by the investigator
    Any laboratory value outside the reference range that the investigator considers to be
    of clinical relevance
    Any evidence of a concomitant disease judged as clinically relevant by the
    investigator
    Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
    immunological or hormonal disorders
    Surgery of the gastrointestinal tract that could interfere with kinetics of the trial
    medication (except appendectomy and simple hernia repair)
    Diseases of the central nervous system (including but not limited to any kind of
    eizures or stroke), and other relevant neurological or psychiatric disorders
    History of relevant orthostatic hypotension, fainting spells, or blackouts
    Chronic or relevant acute infections including HIV, viral hepatitis and (or)
    tuberculosis or evidence of tuberculosis infection as defined by a positive
    QuantiFERON TB-Gold (or TSPOT) test. Subjects with a positive QuantiFERON TB-Gold (or
    T-SPOT) test will not participate in the study.
    History of relevant allergy or hypersensitivity (including allergy to the trial
    medication or its excipients)
    Intake of biologic agents other than current study medication or drugs considered
    likely to interfere with the safe conduct of the study
    Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10
    half-lives of the respective drug prior to administration of trial medication
    Within 10 days prior to administration of trial medication, use of drugs that might
    reasonably influence the results of the trial or that might prolong the QT/QTc
    interval
    Participation in another trial (including bioequivalence trial) with an
    investigational drug within 90 days or 5 half-lives (whichever is greater) prior to
    planned administration of trial medication
    Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
    Inability to refrain from smoking on specified trial days
    Alcohol abuse (consumption of more than 30 g per day)
    Drug abuse or positive drug screening
    Blood donation of more than 200 mL within 30 days prior to administration of trial
    medication or intended donation during the trial
    Intention to perform excessive physical activities within one week prior to
    administration of trial medication or during the trial
    Inability to comply with dietary regimen of trial site
    A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
    repeatedly greater than 450 ms) or any other relevant ECG finding at screening
    A history of additional risk factors for Torsades de Pointes (such as heart failure,
    hypokalemia, or family history of Long QT Syndrome)
    Have received any live bacterial or live viral vaccination in the 12 weeks prior to
    the date of screening. Subjects must agree not to receive a live bacterial or live
    viral vaccination during the study and up to 12 months after the last administration
    of study drug
    Have received Bacille Calmette-Guerin (BCG) vaccination in the 12 months prior to the
    date of screening. Subjects must agree not to receive BCG vaccination during the study
    and up to 12 months after the last administration of study drug
    Subject is assessed as unsuitable for inclusion by the investigator, for instance,
    because considered not able to understand and comply with study requirements, or has a
    condition that would not allow safe participation in the study
    Signs of cataract at screening by slit lamp test

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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