None listed
Conditions
Interventions
investigational material(s)
Generic name etc : BI 894416
INN of investigational material : -
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and Administration for Inv
Sponsors
Nippon Boehringer Ingelheim Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Healthy male subjects according to the assessment of the investigator, as based on a complete medical history, including a medical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests 2.Japanese ethnicity, according to the following criteria: -born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese 3.Age of 20 to 45 years (inclusive) at screening 4.BMI of 18.5 to 25.0 kg/m2 (inclusive) at screening 5.Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation 6.Male subjects with WOCBP partner who are willing to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 90 days thereafter.
Exclusion criteria
Exclusion criteria: 1.Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2.Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm 3.Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4.Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5.Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6.Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication, except appendectomy or simple hernia repair 7.Diseases of the central nervous system, including but not limited to, any kind of seizures or stroke, and other relevant neurological or psychiatric disorders 8.History of relevant orthostatic hypotension, fainting spells, or blackouts 9.Chronic or relevant acute infections 10.History of relevant allergy or hypersensitivity, including allergy to the trial medication or its excipients 11.Use of drugs within 30 d of planned administration of trial medication that might reasonably influence the results of the trial, including drugs that cause QT/QTc interval prolongation 12.Intake of an investigational drug in another clinical trial within 60 d of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered 13.Smoker, unless the subject quit smoking for at least 12 months prior to first planned administration of trial medication 14.Inability to refrain from smoking during trial 15.Alcohol abuse, i.e. consumption of more than 30 g per day 16.Drug abuse or positive drug screening 17.Blood donation of more than 400 mL within 12 weeks, or 200 mL within 30 d, or plasma donation within 2 weeks prior to administration, or intended blood donation during the trial 18.Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial 19.Inability to comply with the dietary regimen of the trial site 20.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 21.A history of additional risk factors for Torsade de Pointes, such as heart failure, hypokalaemia, or family history of Long QT Syndrome 22.Subject is assessed by the investigator as unsuitable for inclusion, because, for instance, the subject is not considered able to understand and comply with trial requirements, or has a condition that would not allow safe participation in the trial 23.History of disease that affects the present situation In addition, the following trial-specific exclusion criteria apply: 24.History of relevant neurological disorder affecting the peripheral or central nervous system, including, but not limited to, stroke, epilepsy, inflammatory or atrophic diseases affecting the nervous system, cluster headache or any cancer of the nervous system* 25.History of immunological disease except allergy not relevant to the trial, such as mild hay fever or dust mite allergy, and except asthma in childhood or adolescence 26.History of cancer, except successfully treated basal c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety The percentage (%) of subjects with drug related adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Cmax, AUC0 of BI 894416 | — |
Countries
Japan
Outcome results
None listed