Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers
Condition: Healthy
Intervention: BI 1026706; Placebo
Intervention description: oral administration; placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following
      oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects according to the investigator's assessment, based on a complete
             medical history including a physical examination, vital signs (BP, PR), 12-lead ECG,
             and clinical laboratory tests

          -  Chinese ethnicity or Japanese ethnicity, according to the following criteria:

          -  Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4
             ethnic Chinese grandparents who were all born in China

          -  Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and
             grandparents who were all born in Japan

          -  Age of 20 to 45 years (incl.) - BMI of 18.5 to 25 kg/m2 (incl.)

          -  Signed and dated written informed consent prior to admission to the study 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

        Exclusion criteria:

          -  Any finding in the medical examination (including BP, PR or 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
             seizures 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 T-SPOT) test. Subjects with a positive QuantiFERON TB-Gold (or
             T-SPOT) test may participate in the study if further work up (according to local
             practice/guidelines) establishes conclusively that the subject has no evidence of
             active tuberculosis. If presence of latent tuberculosis is established, then treatment
             must have been initiated and maintained according to local country guidelines.

          -  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

          -  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

          -  Male patients who do not agree to minimize the risk of female partners becoming
             pregnant from at least 30 days before the first administration of trial medication and
             until 30 days after trial completion.

          -  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