Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma

Exclusion Criteria

• •Any finding in the medical examination (including BP, PR, echocardiography and echocardiography stress test or ECG and including the neurological examination) is deviating from normal and judged as clinically relevant by the investigator
• •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
• •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 (stress), metabolic, immunological or hormonal disorders
• •Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics 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
• •History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• •Use of drugs within 30 days prior to administration of trial medication that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
• •Participation in another trial where an investigational drug other than BI 894416 has been administered within 60 days or 5 half-lives (whichever is greater) prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug. In case of planned participation in the MRD part in this trial the previous participation in one dose group of the SRD part is allowed if BI 894416 has been administered more than 21 days prior to planned administration of BI 894416 in the MRD part. (Participation in an SRD dose group after the patient has participated in the MRD part is not allowed.)
• •Alcohol abuse (consumption of more than 24 g per day)
• •Drug abuse or positive drug screening
• •Blood donation of more than 100 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)
• •Patient unable or unwilling to comply with study requirements, or has a condition that would not allow safe participation in the study
• •History of relevant neurological disorder affecting the peripheral or central nervous system (this includes, but is not limited to: stroke, epilepsy, inflammatory or atrophic diseases affecting the nervous system, cluster headache or any cancer of the nervous system)
• •History of immunological disease except allergy not relevant to the trial (such as mild hayfever or dust mite allergy) and except asthma in childhood or adolescence
• •History of cancer (other than successfully treated basal cell carcinoma)
• •Use of any drug that could reasonably inhibit platelet aggregation or coagulation (e.g. acetylsalicylic acid) within 10 days prior to administration of trial medication, or planned use during the trial or within 7 days after last dose of trial medication.